The following data is part of a premarket notification filed by Crossbay Medical with the FDA for Crossglide Ets Plus.
| Device ID | K201952 |
| 510k Number | K201952 |
| Device Name: | CrossGlide ETS Plus |
| 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 Barroilhet Drive Hillsborough, CA 94010 |
| Product Code | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-14 |
| Decision Date | 2020-08-05 |