K931115 is an FDA 510(k) clearance for the HATCHER STONE-EMBOLIS EXTRACTOR, a Dislodger, Stone, Biliary (Class II — Special Controls, product code LQR), submitted by Ideal Medical, Inc. (Clearwater, US). The FDA issued a Cleared decision on August 20, 1993, 169 days after receiving the submission on March 4, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K931115 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 04, 1993 |
| Decision Date | August 20, 1993 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LQR — Dislodger, Stone, Biliary |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5010 |