K232370 is an FDA 510(k) clearance for the Percutaneous Nephroscope System. This device is classified as a Kit, Nephroscope (Class II - Special Controls, product code FGA).
Submitted by Karl Storz SE & CO. KG (Tuttlingen, DE). The FDA issued a Cleared decision on May 1, 2024, 267 days after receiving the submission on August 8, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K232370 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2023 |
| Decision Date | May 01, 2024 |
| 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 |