K062720 is an FDA 510(k) clearance for the S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES. This device is classified as a Resectoscope (Class II - Special Controls, product code FJL).
Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on March 22, 2007, 191 days after receiving the submission on September 12, 2006.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K062720 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2006 |
| Decision Date | March 22, 2007 |
| Days to Decision | 191 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJL — Resectoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |