K131364 is an FDA 510(k) clearance for the FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE. This device is classified as a Cystourethroscope (Class II - Special Controls, product code FBO).
Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on January 2, 2014, 234 days after receiving the submission on May 13, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K131364 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2013 |
| Decision Date | January 02, 2014 |
| Days to Decision | 234 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 |