K082066 is an FDA 510(k) clearance for the TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER, a Brush, Endometrial (Class II — Special Controls, product code HFE), submitted by Cook Urological, Inc. (Bloomington, US). The FDA issued a Cleared decision on November 7, 2008, 108 days after receiving the submission on July 22, 2008. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1100.
| 510(k) Number | K082066 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 22, 2008 |
| Decision Date | November 07, 2008 |
| Days to Decision | 108 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 |