ClearanceBrief
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)
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Top companies in NEW

DateFirm and productCodeLinked 510(k)
Sep 19, 2025ETHICON, 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
NEWK192144
Apr 3, 2025Ethicon Endo Surgery, LLC
ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
Open, Classified
NEWK946173
Apr 3, 2025Ethicon Endo Surgery, LLC
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Open, Classified
NEWK133356
Apr 3, 2025Ethicon Endo Surgery, LLC
PDSIIVIO30IN(75CM)USP6-0(M0.7)D/AC-1
Open, Classified
NEWNone listed
Apr 3, 2025Ethicon Endo Surgery, LLC
PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
Open, Classified
NEWK183183
Sep 30, 2024ETHICON, 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
NEWNone listed
Sep 30, 2024ETHICON, LLC
PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP50
Open, Classified
NEWNone listed
Jun 14, 2024Ethicon, 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
NEWK061037
K212380
May 10, 2023Ethicon, 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
NEWK061037
Dec 14, 2022Ethicon, 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
NEWNone listed
Aug 8, 2022Ethicon, Inc.
PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Open, Classified
NEWNone listed
Feb 6, 2020Ethicon, Inc.
1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429
Terminated
NEWK182873
Feb 6, 2020Ethicon, Inc.
1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
Terminated
NEWK182873
Feb 6, 2020Ethicon, Inc.
1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
Terminated
NEWK182873
Oct 4, 2019Ethicon, Inc.
STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
Terminated
NEWK182873
Oct 4, 2019Ethicon, Inc.
STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
Terminated
NEWK182873
Mar 12, 2019Ethicon, 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
NEWNone listed
Mar 12, 2019Ethicon, 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
NEWK061037
Jun 8, 2018Ethicon, 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
NEWNone listed
Jun 8, 2018Ethicon, 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
NEWK061037
Jun 8, 2018Ethicon, 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
NEWK061037
Jan 10, 2018Ethicon, Inc.
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
Terminated
NEWK061037
Jan 10, 2018Ethicon, Inc.
PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
Terminated
NEWK061037
Jan 10, 2018Ethicon, Inc.
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
Terminated
NEWK061037
Oct 27, 2014C 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
NEWNone listed
Jun 3, 2014C 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
NEWK030786
May 1, 2014Teleflex Medical
CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137.
Terminated
NEWK030212
Apr 25, 2014Teleflex Medical
Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48
Terminated
NEWK030212
Dec 6, 2013Ethicon, 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
NEWK113004
Nov 18, 2013Riverpoint 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
NEWK100461
Apr 25, 2013DePuy 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
NEWK043298
Apr 25, 2013DePuy 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
NEWK043298
Apr 25, 2013DePuy 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
NEWK043298
Apr 25, 2013DePuy 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
NEWK043298
Apr 25, 2013DePuy 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
NEWK043298
Nov 19, 2011C 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
NEWK013274
Sep 27, 2010C 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
NEWK013274
May 12, 2009Ethicon, 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
NEWK040004
May 12, 2009Ethicon, 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
NEWK043298
May 12, 2009Ethicon, Inc.
PDS Plus Antibacterial (polydioxanone) Suture Sutures are intended for general soft tissue approximation and/or ligation.
Terminated
NEWK061037

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