Company · US
ETHICON, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2026. Name variants (Inc, Corp, punctuation) are merged.
208510(k) clearances (6 in 12 months)
106recalls (2 in 12 months)
88recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 48 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 33 |
| FTL | Mesh, Surgical, Polymeric | 28 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 26 |
| GCJ | Laparoscope, General & Plastic Surgery | 18 |
| HET | Laparoscope, Gynecologic (And Accessories) | 12 |
| FZP | Clip, Implantable | 11 |
| GDW | Staple, Implantable | 11 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 8 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | 7 |
| GAG | Stapler, Surgical | 6 |
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 6 |
| FTM | Mesh, Surgical | 5 |
| GAN | Suture, Absorbable, Synthetic | 5 |
| KOG | 5 | |
| LDF | Electrode, Pacemaker, Temporary | 5 |
| LMF | Agent, Absorbable Hemostatic, Collagen Based | 4 |
| OMD | Cutaneous Tissue Adhesive With Mesh | 4 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 3 |
| FMF | Syringe, Piston | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 25, 2026 | K253394 | Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture ETHICON, Inc. | GAM |
| May 18, 2026 | K252047 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices ETHICON, Inc. | NEW |
| Mar 27, 2026 | K253572 | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotl ETHICON, Inc. | GAW |
| Feb 6, 2026 | K253852 | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture ETHICON, Inc. | GAM |
| Dec 22, 2025 | K252743 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Dev ETHICON, Inc. | GAM |
| Nov 12, 2025 | K243897 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture ETHICON, Inc. | NEW |
| Nov 15, 2022 | K221744 | STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device ETHICON, Inc. | GAM |
| Feb 22, 2022 | K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture ETHICON, Inc. | NEW |
| Dec 7, 2021 | K213512 | DERMABOND PRINEO Skin Closure System ETHICON, Inc. | OMD |
| Dec 21, 2020 | K201996 | Monocryl Plus Antibacterial Suture ETHICON, Inc. | GAM |
| Sep 17, 2020 | K201686 | GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT Introducer and Catheter Guide, GYNECARE ETHICON, Inc. | OTN |
| Aug 6, 2020 | K201143 | VICRYL Mesh ETHICON, Inc. | FTL |
| Mar 25, 2020 | K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device ETHICON, Inc. | NEW |
| Dec 18, 2019 | K192580 | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device ETHICON, Inc. | GAM |
| Oct 22, 2019 | K191373 | VICRYL Mesh ETHICON, Inc. | FTL |
| Jun 27, 2019 | K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable S ETHICON, Inc. | GAM |
| Jan 10, 2019 | K182873 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, ETHICON, Inc. | NEW |
| Sep 28, 2018 | K181652 | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture ETHICON, Inc. | GAM |
| Aug 10, 2018 | K181151 | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System ETHICON, Inc. | PWJ |
| Aug 2, 2018 | K173923 | Temporary Cardiac Pacing Wire ETHICON, Inc. | LDF |
| Jul 26, 2018 | K181268 | PROLENE (Polypropylene) 3D Patch ETHICON, Inc. | FTL |
| Jul 6, 2018 | K173019 | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Troca ETHICON, Inc. | PWJ |
| Jul 2, 2018 | K180910 | ULTRAPRO Mesh and ULTRAPRO ADVANCED ETHICON, Inc. | FTL |
| Jun 28, 2018 | K180829 | PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable ETHICON, Inc. | FTL |
| Jun 28, 2018 | K173162 | GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guid ETHICON, Inc. | PWJ |
| Nov 1, 2017 | K170767 | Surgical Stainless Steel Suture, Stainless Steel Suture ETHICON, Inc. | GAQ |
| Oct 5, 2017 | K172089 | PROLENE Soft Polypropylene Mesh ETHICON, Inc. | FTL |
| Apr 21, 2017 | K163645 | DERMABOND PRINEO Skin Closure System Ethicon, LLC | OMD |
| Mar 11, 2017 | K163152 | PROLENE Soft Polypropylene Mesh ETHICON, Inc. | FTL |
| Jul 12, 2016 | K161726 | E-Pack Procedure Kit ETHICON, Inc. | GAM |
| Jun 3, 2016 | K153611 | Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Ethicon, LLC | GAM |
| Nov 25, 2015 | K152490 | DERMABOND PRINEO Skin Closure System ETHICON, Inc. | OMD |
| Oct 22, 2015 | K152096 | DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive ETHICON, Inc. | MPN |
| Aug 13, 2015 | K151200 | STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device ETHICON, Inc. | GAM |
| Jul 2, 2015 | K150670 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device ETHICON, Inc. | NEW |
| Mar 26, 2015 | K142822 | PLIASURE Polyglycolide Synthetic Absorbable Suture ETHICON, Inc. | GAM |
| Oct 23, 2014 | K141560 | ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE ETHICON, Inc. | FTL |
| Oct 15, 2014 | K141776 | STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES ETHICON, Inc. | NEW |
| May 30, 2014 | K133198 | ULTRAPRO COMFORT PLUG ETHICON, Inc. | FTL |
| Mar 10, 2014 | K133864 | DERMABOND PRINEO SKIN CLOSURE SYSTEM ETHICON, Inc. | OMD |
| Feb 28, 2014 | K132580 | COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE ETHICON, Inc. | GAM |
| Dec 6, 2013 | K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE ETHICON, Inc. | GAW |
| Sep 27, 2013 | K131656 | MORCELLEX SIGMA GENERATOR ETHICON, Inc. | HET |
| Aug 23, 2013 | K132054 | GYNECARE TVT EXACT CONTINENCE SYSTEM ETHICON, Inc. | OTN |
| Feb 5, 2013 | K123114 | ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE ETHICON, Inc. | GDW |
| Jun 11, 2012 | K113205 | ARTISYN Y-SHAPED MESH ETHICON, Inc. | OTO |
| Dec 20, 2011 | K113004 | PDS(TM) BARBED SUTURES ETHICON, Inc. | NEW |
| Dec 2, 2011 | K111751 | VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS ETHICON, Inc. | HIN |
| Jul 1, 2010 | K100936 | GYNECARE TVT ABBREVO CONTINENCE SYSTEM ETHICON, Inc. | OTN |
| May 4, 2010 | K100423 | DERMABOND NX ADHESIVE MODEL: DNX6, DNX12 ETHICON, Inc. | MPN |
Newest 50 of 208.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2026 | Ethicon, LLC ETHILON Nylon Suture, Product Code 697G Open, Classified |
GAQ | K946173 |
| Oct 14, 2026 | Ethicon, LLC PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H Open, Classified |
GAQ | K946173 |
| Sep 19, 2025 | ETHICON, LLC STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11. Open, Classified |
NEW | K192144 |
| Feb 4, 2025 | Ethicon, LLC ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H.
Not sold in US Open, Classified |
GAW | None listed |
| Feb 4, 2025 | Ethicon, LLC PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic an Open, Classified |
GAW | K946173 |
| Feb 4, 2025 | Ethicon, LLC PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophtha Open, Classified |
GAW | K133356 |
| Nov 19, 2024 | ETHICON, INC. MONOCRYL" (poliglecaprone 25) Suture REF Y936H
MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues Open, Classified |
GAN | K964072 |
| Nov 7, 2024 | Ethicon, Inc. Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H Open, Classified |
GAM | K183183 |
| Sep 30, 2024 | ETHICON, LLC PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z Open, Classified |
NEW | None listed |
| Sep 30, 2024 | ETHICON, LLC PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP50 Open, Classified |
NEW | None listed |
| Jun 14, 2024 | Ethicon, Inc. MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated.
PRODUCT CODE:
MCP266H13
MCP3 Open, Classified |
GAM | K201996 |
| Jun 14, 2024 | Ethicon, Inc. MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated
PRODUCT CODE:
Y315H
Y345H
Y359H
Y398 Open, Classified |
GAN | K960653 K964072 |
| Jun 14, 2024 | Ethicon, Inc. PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. The Open, Classified |
NEW | K061037 K212380 |
| Jun 14, 2024 | Ethicon, Inc. PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are p Open, Classified |
GAM | K183183 |
| Jun 14, 2024 | Ethicon, Inc. VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.
PRODUCT COD Open, Classified |
GAM | K181652 |
| Jun 14, 2024 | Ethicon, Inc. VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue Open, Classified |
GAM | K022269 |
| May 22, 2024 | Ethicon, Inc. SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979. Open, Classified |
LMF | None listed |
| Apr 12, 2024 | Ethicon, Inc. STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM-
Indicated for use in soft tissue approximation Open, Classified |
GAM | K192580 |
| May 10, 2023 | Ethicon, Inc. PDS Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tis Open, Classified |
NEW | K061037 |
| Dec 14, 2022 | Ethicon, Inc. PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1
Product Code: Z340H
For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected Open, Classified |
NEW | None listed |
| Oct 31, 2022 | Ethicon, Inc. STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.
Product No.: SXMD1B405-12 Open, Classified |
GAM | K151200 |
| Aug 8, 2022 | Ethicon, Inc. PDS II (polydioxanone) Suture, Product Code Z771D
4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles Open, Classified |
NEW | None listed |
| Mar 24, 2022 | Ethicon, Inc. STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12]. Open, Classified |
GAM | K122898 |
| Jan 4, 2021 | Ethicon, Inc. Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions
Product Code: DNX12 Terminated |
MPN | K100423 K152096 |
| Oct 23, 2020 | Ethicon, Inc. PROCEED Surgical Mesh
Hernia Mesh Oval, 15 cm x 20 cm Terminated |
FTL | K060713 |
| Sep 9, 2020 | Ethicon, Inc. VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligation.
Product Code: V960G Terminated |
GAM | None listed |
| Jun 10, 2020 | Ethicon, Inc. PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes
EH7457G
EH7983G
FV768
FV769
FV7771
U7058
U7059
W1782
W1784
W1819
W1820
W818
W819
W870 Open, Classified |
GAP | K946173 |
| Feb 6, 2020 | Ethicon, Inc. 1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429 Terminated |
NEW | K182873 |
| Feb 6, 2020 | Ethicon, Inc. 1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402 Terminated |
NEW | K182873 |
| Feb 6, 2020 | Ethicon, Inc. 1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201 Terminated |
NEW | K182873 |
| Feb 4, 2020 | Ethicon, Inc. Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture. Terminated |
GAM | K022269 |
| Oct 4, 2019 | Ethicon, Inc. STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle
Product code: SXPP1B401 suture Terminated |
NEW | K182873 |
| Oct 4, 2019 | Ethicon, Inc. STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle
Product code: SXPP1B430 suture Terminated |
NEW | K182873 |
| Apr 19, 2019 | Ethicon, Inc. ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX
Product Code: X865W
Product Usage:
ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or lig Terminated |
GAQ | K946173 |
| Apr 19, 2019 | Ethicon, Inc. ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1
Product Code: X425H
Product Usage:
ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or li Terminated |
GAQ | K946173 |
| Mar 12, 2019 | Ethicon, Inc. PDS II SUTURE 18"(45CM) 2-0 VIO
Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur a Terminated |
NEW | None listed |
| Mar 12, 2019 | Ethicon, Inc. VICRYL PLUS Sutures:
VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO
VICRYL PLUS SUTURE 18"(45CM) 0 UND
VICRYL PLUS SUTURE 18"(45CM) 0 VIO
VICRYL PLUS SUTURE 18"(45CM) 0 VIO)
VICRYL PLUS SUTURE 18"(45CM) 1 VIO Terminated |
NEW | K061037 |
| Mar 12, 2019 | Ethicon, Inc. VICRYL Sutures
VICRYL SUTURE 18"(45CM) 0 VIO
VICRYL SUTURE 18"(45CM) 4-0 UND
VICRYL SUTURE 18"(45CM) 2-0 VIO
VICRYL SUTURE 18"(45CM) 0 VIO
VICRYL SUTURE 18"(45CM) 2-0 VIO
VICRYL CT VIO 8X18IN 0 S/A CT Terminated |
GAM | K022715 |
| Dec 18, 2018 | Ethicon, Inc. PERMA-HAND Silk Suture Size 5, Black 30" (75cm)
Double Armed LR Needles, Product Code 485T
Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approximation and/or ligation Terminated |
GAP | K946173 |
| Jun 8, 2018 | Ethicon, Inc. PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle
Product Code: Z511G (GTIN 10705031061347) Terminated |
NEW | None listed |
| Jun 8, 2018 | Ethicon, Inc. PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle
Product Code: PDP493G (GTIN 10705031203945) Terminated |
NEW | K061037 |
| Jun 8, 2018 | Ethicon, Inc. PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle
Product Code: PDP507G (GTIN 10705031203983) Terminated |
NEW | K061037 |
| May 7, 2018 | Ethicon, Inc. PRONOVA SUTURE BLUE 122CM M1.5, D10189 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067 Terminated |
GAW | K133356 |
Newest 50 of 106.