The following data is part of a premarket notification filed by Crossbay Medical with the FDA for Crossbay Endometrial Tissue Sampler (ets).
| Device ID | K192534 |
| 510k Number | K192534 |
| Device Name: | CrossBay Endometrial Tissue Sampler (ETS) |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| Applicant | CrossBay Medical 13240 Evening Creek Drive, Suite 304 San Diego, CA 92128 |
| Contact | Piush Vidyarthi |
| Correspondent | Cindy Domecus Domecus Consulting Services, LLC 1171 Barroihet Drive Hillsborough, CA 94010 |
| Product Code | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-16 |
| Decision Date | 2020-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850012760054 | K192534 | 000 |