510(k) K043193 ยท FAD Stent, Ureteral
BARD INLAYOPTIMA URETERAL STENT WITH SUTURE
| Applicant | C.R. Bard, Inc., Covington GA, US |
| Decision | Substantially Equivalent, Dec 7, 2004 |
| Received | Nov 18, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043193
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2025 | C.R. Bard Inc Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit
REF 787614 Open, Classified |
FAD | None listed |
| Dec 11, 2025 | C.R. Bard Inc BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit
REF 788426 Open, Classified |
FAD | None listed |
| Dec 11, 2025 | C.R. Bard Inc BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit
REF 788630 Open, Classified |
FAD | None listed |
| Dec 11, 2025 | C.R. Bard Inc BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit
REF 78826 Open, Classified |
FAD | None listed |
| Oct 13, 2016 | C.R. Bard, Inc. Bard Inlay Optima Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with Stent and Multi- Length Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014. Terminated |
FAD | None listed |
| Oct 13, 2016 | C.R. Bard, Inc. Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014. Terminated |
FAD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.