K961248 is an FDA 510(k) clearance for the BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS. 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 May 28, 1996, 57 days after receiving the submission on April 1, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4680.
| 510(k) Number | K961248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 1996 |
| Decision Date | May 28, 1996 |
| Days to Decision | 57 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 |