K770943 is an FDA 510(k) clearance for the ENDOSCOPE, UROLOGICAL, FEMALE. This device is classified as a Panendoscope (urethroscope) (Class II - Special Controls, product code FAL).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 18, 1977, 146 days after receiving the submission on May 25, 1977.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K770943 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 1977 |
| Decision Date | October 18, 1977 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FAL — Panendoscope (urethroscope) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |