PGK
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cannula, Injector, Uterine, Endometrial Biopsy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Medical specialty
- Obstetrics/Gynecology
- FDA definition
- to deliver saline and/or contrast media to complete saline infusion sonohysterography and/or hysterosalpingogram respectively and to obtain endometrial biopsy
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE (K133144) | Crossbay Medical, Inc. | 2014-03-19 |
| SONOHYSTEROGRAPHY BIOPSY DEVICE (K060908) | Cook Urological, Inc. | 2006-06-29 |
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Every clearance here is in the API, with alerts when new ones post.