K950433 is an FDA 510(k) clearance for the KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES. This device is classified as a Kit, Nephroscope (Class II - Special Controls, product code FGA).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on March 15, 1995, 41 days after receiving the submission on February 2, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K950433 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 1995 |
| Decision Date | March 15, 1995 |
| Days to Decision | 41 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 |