K170603 is an FDA 510(k) clearance for the Tao Brush I.U.M.C. Endometrial Sampler. This device is classified as a Brush, Endometrial (Class II - Special Controls, product code HFE).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on May 24, 2017, 84 days after receiving the submission on March 1, 2017.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1100.
| 510(k) Number | K170603 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2017 |
| Decision Date | May 24, 2017 |
| Days to Decision | 84 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 |