Panels › General, Plastic Surgery › Product code NEW · Class 2
Suture, Surgical, Absorbable, Polydioxanone
Regulation 878.4840
6510(k)s in 12 months (67 all time)
0recalls in 12 months (40 all time)
32recalls that name a 510(k)
Top companies in NEW
| Company | 510(k)s | Recalls |
|---|---|---|
| ETHICON, Inc. | 9 | 24 |
| DePuy Mitek, Inc., a Johnson & Johnson Co. | 0 | 5 |
| Surgical Specialties Corp | 5 | 0 |
| C P Medical | 0 | 4 |
| Ethicon Endo Surgery, LLC | 0 | 4 |
| Hans Biomed Corporation | 4 | 0 |
| Demetech Corp. | 3 | 0 |
| Depuy Mitek | 3 | 0 |
| Feeltech Co., Ltd. | 3 | 0 |
| Surgical Specialties Corp. Dba Angiotech | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Apr 3, 2025 | Ethicon Endo Surgery, LLC ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH Open, Classified |
NEW | K946173 |
| Apr 3, 2025 | Ethicon Endo Surgery, LLC PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM Open, Classified |
NEW | K133356 |
| Apr 3, 2025 | Ethicon Endo Surgery, LLC PDSIIVIO30IN(75CM)USP6-0(M0.7)D/AC-1 Open, Classified |
NEW | None listed |
| Apr 3, 2025 | Ethicon Endo Surgery, LLC PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP Open, Classified |
NEW | 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. 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Jan 10, 2018 | Ethicon, Inc. PDS Plus Antibacterial (Polydioxanone) Suture
Size 0 PDS Plus Violet 36
Single Armed CTB-1 Needle Terminated |
NEW | K061037 |
| Jan 10, 2018 | Ethicon, Inc. PDS Plus Antibacterial (Polydioxanone) Suture
Size 1 PDS PLUS Violet 27
Single Armed OS-4 Needle Terminated |
NEW | K061037 |
| Jan 10, 2018 | Ethicon, Inc. PDS Plus Antibacterial (Polydioxanone) Suture
Size 0 PDS Plus Violet 36
Single Armed CT-1 Needle Terminated |
NEW | K061037 |
| Oct 27, 2014 | C P Medical, Inc. Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. Terminated |
NEW | None listed |
| Jun 3, 2014 | C P Medical Inc. Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. Product is labeled sterile. The product is sealed inside an inner foil pouch with Terminated |
NEW | K030786 |
| May 1, 2014 | Teleflex Medical CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137. Terminated |
NEW | K030212 |
| Apr 25, 2014 | Teleflex Medical Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48 Terminated |
NEW | K030212 |
| Dec 6, 2013 | Ethicon, Inc. Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969.
Intended for general soft tissue approximation where use of an absorbable suture is approp Terminated |
NEW | K113004 |
| Nov 18, 2013 | Riverpoint Medical, LLC Polyglycolic-Lactic Acid Absorbable Surgical Suture
Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***"
PGLA surgical suture is indicated for use in Terminated |
NEW | K100461 |
| Apr 25, 2013 | DePuy Mitek, Inc., a Johnson & Johnson Co. ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116.
For use in general soft tissue approximation, and/or ligation, including orthopedi Terminated |
NEW | K043298 |
| Apr 25, 2013 | DePuy Mitek, Inc., a Johnson & Johnson Co. ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115.
For use in general soft tissue approximation, and/or ligation, including orthopedic procedur Terminated |
NEW | K043298 |
| Apr 25, 2013 | DePuy Mitek, Inc., a Johnson & Johnson Co. ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114.
For use in general soft tissue approximation, and/or ligation, including orthopedic procedu Terminated |
NEW | K043298 |
| Apr 25, 2013 | DePuy Mitek, Inc., a Johnson & Johnson Co. ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223113.
For use in general soft tissue approximation, and/or ligation, including orthopedic procedures. Terminated |
NEW | K043298 |
| Apr 25, 2013 | DePuy Mitek, Inc., a Johnson & Johnson Co. ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111.
For use in general soft tissue approximation, and/or ligation, including orthopedic procedures. Terminated |
NEW | K043298 |
| Nov 19, 2011 | C P Medical Inc. Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. The outer sterile barrier seal is intact. Terminated |
NEW | K013274 |
| Sep 27, 2010 | C P Medical Product is labeled in part: "CP-SM397A-02...Mono-Dox Violet Monofilament Polydioxanone Synthetic Absorbable Sterile Suture. Do Not Resterilize.... 4/0 (1.5 metric) 30" (75cm) Rx Only...LOT L0535440 E Terminated |
NEW | K013274 |
| May 12, 2009 | Ethicon, Inc. Orthocord Suture, DePuy Mitek, a Johnson & Johnson Company; . DePuy Mitek, Inc.
325 Paramount Drive, Raynham, MA 02767
Sutures are intended for general soft tissue approximation and/or ligation. Terminated |
NEW | K040004 |
| May 12, 2009 | Ethicon, Inc. Orthocord Blue Braided Composite Suture, DePuy Mitek, A Johnson & Johnson Company, Meets USP and EP, except for diameter.
DePuy Mitek, Inc.
325 Paramount Drive, Raynham, MA 02767
Sutures are intended Terminated |
NEW | K043298 |
| May 12, 2009 | Ethicon, Inc. PDS Plus Antibacterial (polydioxanone) Suture
Sutures are intended for general soft tissue approximation and/or ligation. Terminated |
NEW | K061037 |
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