K991426 is an FDA 510(k) clearance for the MAHE INSTRUMENTS, a Resectoscope, Working Element (Class II — Special Controls, product code FDC), submitted by Mahe Intl., Inc. (Nashville, US). The FDA issued a Cleared decision on August 5, 1999, 104 days after receiving the submission on April 23, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K991426 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 23, 1999 |
| Decision Date | August 05, 1999 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FDC — Resectoscope, Working Element |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |