K922542 is an FDA 510(k) clearance for the GRASPING FORCEPS. This device is classified as a Dislodger, Stone, Flexible (Class II - Special Controls, product code FGO).
Submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on August 19, 1992, 82 days after receiving the submission on May 29, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4680.
| 510(k) Number | K922542 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 1992 |
| Decision Date | August 19, 1992 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FGO — Dislodger, Stone, Flexible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4680 |