The following data is part of a premarket notification filed by Crossbay Medical, Inc. with the FDA for Sonosure Sonohysterography & Endometrial Sampling Device.
| Device ID | K133144 |
| 510k Number | K133144 |
| Device Name: | SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE |
| Classification | Cannula, Injector, Uterine, Endometrial Biopsy |
| Applicant | CrossBay Medical, Inc. 17141 MURPHY AVE, SUITE 5C Irvine, CA 94901 |
| Contact | Cindy Domecus |
| Correspondent | Cindy Domecus CrossBay Medical, Inc. 17141 MURPHY AVE, SUITE 5C Irvine, CA 94901 |
| Product Code | PGK |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-03-19 |
| Summary: | summary |