POY — Post Breast Biopsy Hemostatic Breast Compression Device Class II
FDA product code POY covers "Post Breast Biopsy Hemostatic Breast Compression Device", a Class II medical device regulated under 21 CFR 892.1710. Submissions are reviewed by the Radiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- POY
- Device Class
- Class II
- Regulation Number
- 892.1710
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Radiology
- Implant
- No
Definition
To achieve and maintain hemostasis of a breast biopsy wound site.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K163388 | xpress bcd | XPress BCD Breast Compression Device | July 19, 2017 |