K112763 is an FDA 510(k) clearance for the MATRIXBRUSH ENDOMETRIAL SAMPLER, a Brush, Endometrial (Class II — Special Controls, product code HFE), submitted by Post Oak Innovations, Inc. (Austin, US). The FDA issued a Cleared decision on June 18, 2012, 270 days after receiving the submission on September 22, 2011. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1100.
| 510(k) Number | K112763 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 22, 2011 |
| Decision Date | June 18, 2012 |
| Days to Decision | 270 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 |