K940594 is an FDA 510(k) clearance for the KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE. This device is classified as a Kit, Nephroscope (Class II - Special Controls, product code FGA).
Submitted by KARL STORZ Endoscopy-America, Inc. (Washington, US). The FDA issued a Cleared decision on September 9, 1994, 212 days after receiving the submission on February 9, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K940594 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 1994 |
| Decision Date | September 09, 1994 |
| Days to Decision | 212 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 |