K941298 is an FDA 510(k) clearance for the IUMC ENDOMETRIAL SAMPLER, a Brush, Endometrial (Class II — Special Controls, product code HFE), submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on February 13, 1995, 333 days after receiving the submission on March 17, 1994. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1100.
| 510(k) Number | K941298 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 17, 1994 |
| Decision Date | February 13, 1995 |
| Days to Decision | 333 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HFE — Brush, Endometrial |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1100 |