K992141 is an FDA 510(k) clearance for the OLYMPUS WORKING ELEMENT FOR PROBES. This device is classified as a Resectoscope, Working Element (Class II - Special Controls, product code FDC).
Submitted by Olympus Winter & Ibe GmbH (Melville, US). The FDA issued a Cleared decision on September 29, 1999, 97 days after receiving the submission on June 24, 1999.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K992141 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 1999 |
| Decision Date | September 29, 1999 |
| Days to Decision | 97 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 |