K945907 is an FDA 510(k) clearance for the KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURES. This device is classified as a Urethroscope (Class II - Special Controls, product code FGC).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on May 12, 1995, 161 days after receiving the submission on December 2, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K945907 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 1994 |
| Decision Date | May 12, 1995 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGC — Urethroscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |