510(k) K182873 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Jan 10, 2019 |
| Received | Oct 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182873
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2020 | Ethicon, Inc. 1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201 Terminated |
NEW | None listed |
| Feb 6, 2020 | Ethicon, Inc. 1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402 Terminated |
NEW | None listed |
| Feb 6, 2020 | Ethicon, Inc. 1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429 Terminated |
NEW | None listed |
| Oct 4, 2019 | Ethicon, Inc. STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle
Product code: SXPP1B430 suture Terminated |
NEW | None listed |
| Oct 4, 2019 | Ethicon, Inc. STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle
Product code: SXPP1B401 suture Terminated |
NEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.