# Post Breast Biopsy Hemostatic Breast Compression Device
> **Product code: POY** · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.1710
## Classification
- **FDA Product Code:** POY
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 892.1710
- **Review panel:** SU
- **Medical specialty:** Radiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

To achieve and maintain hemostasis of a breast biopsy wound site.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=POY)
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