K133144 is an FDA 510(k) clearance for the SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE. This device is classified as a Cannula, Injector, Uterine, Endometrial Biopsy (Class II - Special Controls, product code PGK).
Submitted by Crossbay Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on March 19, 2014, 153 days after receiving the submission on October 17, 2013.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530. To Deliver Saline And/or Contrast Media To Complete Saline Infusion Sonohysterography And/or Hysterosalpingogram Respectively And To Obtain Endometrial Biopsy.
| 510(k) Number | K133144 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 2013 |
| Decision Date | March 19, 2014 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PGK — Cannula, Injector, Uterine, Endometrial Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |
| Definition | To Deliver Saline And/or Contrast Media To Complete Saline Infusion Sonohysterography And/or Hysterosalpingogram Respectively And To Obtain Endometrial Biopsy |