# Cannula, Injector, Uterine, Endometrial Biopsy
> **Product code: PGK** · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.4530
## Classification
- **FDA Product Code:** PGK
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 884.4530
- **Review panel:** OB
- **Medical specialty:** Obstetrics/Gynecology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

to deliver saline and/or contrast media to complete saline infusion sonohysterography and/or hysterosalpingogram respectively and to obtain endometrial biopsy

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PGK)
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