K914112 is an FDA 510(k) clearance for the METAL URETERAL BASKET STONE DISLODGER, FLAT WIRE. This device is classified as a Dislodger, Stone, Flexible (Class II - Special Controls, product code FGO).
Submitted by Annex Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on February 28, 1992, 168 days after receiving the submission on September 13, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4680.
| 510(k) Number | K914112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 1991 |
| Decision Date | February 28, 1992 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGO — Dislodger, Stone, Flexible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4680 |