K151308 is an FDA 510(k) clearance for the Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set. This device is classified as a Kit, Nephroscope (Class II - Special Controls, product code FGA).
Submitted by Schoelly Fiberoptic GmbH (Denzlingen, DE). The FDA issued a Cleared decision on February 9, 2016, 267 days after receiving the submission on May 18, 2015.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K151308 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2015 |
| Decision Date | February 09, 2016 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGA — Kit, Nephroscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |