K061646 is an FDA 510(k) clearance for the LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES. This device is classified as a Cystourethroscope (Class II - Special Controls, product code FBO).
Submitted by Laserscope (San Jose, US). The FDA issued a Cleared decision on June 27, 2006, 15 days after receiving the submission on June 12, 2006.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K061646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 2006 |
| Decision Date | June 27, 2006 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FBO — Cystourethroscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |