K043193 is an FDA 510(k) clearance for the BARD INLAYOPTIMA URETERAL STENT WITH SUTURE. This device is classified as a Stent, Ureteral (Class II - Special Controls, product code FAD).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on December 7, 2004, 19 days after receiving the submission on November 18, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4620.
| 510(k) Number | K043193 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2004 |
| Decision Date | December 07, 2004 |
| Days to Decision | 19 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAD — Stent, Ureteral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4620 |