510(k) K061037 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
PDS PLUS ANTIBACTERIAL SUTURE
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Jul 14, 2006 |
| Received | Apr 14, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061037
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | 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 | None listed |
| 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 | 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 | None listed |
| Jan 10, 2018 | Ethicon, Inc. PDS Plus Antibacterial (Polydioxanone) Suture
Size 0 PDS Plus Violet 36
Single Armed CT-1 Needle Terminated |
NEW | None listed |
| Jan 10, 2018 | Ethicon, Inc. PDS Plus Antibacterial (Polydioxanone) Suture
Size 1 PDS PLUS Violet 27
Single Armed OS-4 Needle Terminated |
NEW | None listed |
| Jan 10, 2018 | Ethicon, Inc. PDS Plus Antibacterial (Polydioxanone) Suture
Size 0 PDS Plus Violet 36
Single Armed CTB-1 Needle Terminated |
NEW | None listed |
| May 12, 2009 | Ethicon, Inc. PDS Plus Antibacterial (polydioxanone) Suture
Sutures are intended for general soft tissue approximation and/or ligation. Terminated |
NEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.