K904079 is an FDA 510(k) clearance for the BARD UTERINE MANIPULATOR. This device is classified as a Cannula, Manipulator/injector, Uterine (Class II - Special Controls, product code LKF).
Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on February 7, 1991, 155 days after receiving the submission on September 5, 1990.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K904079 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 1990 |
| Decision Date | February 07, 1991 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | LKF — Cannula, Manipulator/injector, Uterine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |