PGK — Cannula, Injector, Uterine, Endometrial Biopsy Class II
FDA product code PGK covers "Cannula, Injector, Uterine, Endometrial Biopsy", a Class II medical device regulated under 21 CFR 884.4530. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PGK
- Device Class
- Class II
- Regulation Number
- 884.4530
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
to deliver saline and/or contrast media to complete saline infusion sonohysterography and/or hysterosalpingogram respectively and to obtain endometrial biopsy