Cannula, Injector, Uterine, Endometrial Biopsy
The Uterine Injector Cannula for Endometrial Biopsy is a gynecological device used to deliver saline and/or contrast media for saline infusion sonohysterography and hysterosalpingography, and to obtain endometrial tissue biopsies. It is an FDA Class 2 device regulated under 21 CFR 884.4530, requiring 510(k) premarket notification, within the Obstetrics and Gynecology (OB) medical specialty. The product code is PGK. This device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PGK
- Device Class
- FDA class 2
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
Definition
to deliver saline and/or contrast media to complete saline infusion sonohysterography and/or hysterosalpingogram respectively and to obtain endometrial biopsy
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.