K771149 is an FDA 510(k) clearance for the ENDOMETRIAL ASPIRATION BIOSPY KIT 182341. This device is classified as a Curette, Suction, Endometrial (and Accessories) (Class II - Special Controls, product code HHK).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1977, 30 days after receiving the submission on June 27, 1977.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1175.
| 510(k) Number | K771149 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 1977 |
| Decision Date | July 27, 1977 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HHK — Curette, Suction, Endometrial (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1175 |