K771302 is an FDA 510(k) clearance for the PFISTER-SCHWARTZ STONE RETRIEVER. This device is classified as a Dislodger, Stone, Flexible (Class II - Special Controls, product code FGO).
Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Walker, US). The FDA issued a Cleared decision on August 2, 1977, 18 days after receiving the submission on July 15, 1977.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4680.
| 510(k) Number | K771302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 1977 |
| Decision Date | August 02, 1977 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FGO — Dislodger, Stone, Flexible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4680 |