K192534 is an FDA 510(k) clearance for the CrossBay Endometrial Tissue Sampler (ETS). This device is classified as a Curette, Suction, Endometrial (and Accessories) (Class II - Special Controls, product code HHK).
Submitted by Crossbay Medical (San Diego, US). The FDA issued a Cleared decision on March 25, 2020, 191 days after receiving the submission on September 16, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1175.
| 510(k) Number | K192534 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2019 |
| Decision Date | March 25, 2020 |
| Days to Decision | 191 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HHK - Curette, Suction, Endometrial (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1175 |