K950125 is an FDA 510(k) clearance for the KARL STORZ BOUGIES AND DILATORS. This device is classified as a Bougie, Urological (Class I - General Controls, product code FAX).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on February 7, 1995, 26 days after receiving the submission on January 12, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5520.
| 510(k) Number | K950125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 1995 |
| Decision Date | February 07, 1995 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAX — Bougie, Urological |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5520 |