K921233 is an FDA 510(k) clearance for the BARD 4-WIRE URETEROSCOPIC STONE. This device is classified as a Dislodger, Stone, Basket, Ureteral, Metal (Class II - Special Controls, product code FFL).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on April 27, 1992, 45 days after receiving the submission on March 13, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4680.
| 510(k) Number | K921233 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 1992 |
| Decision Date | April 27, 1992 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFL — Dislodger, Stone, Basket, Ureteral, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4680 |