Post Breast Biopsy Hemostatic Breast Compression Device
The Post Breast Biopsy Hemostatic Breast Compression Device (product code POY) is a Class 2 radiology device intended to achieve and maintain hemostasis of a breast biopsy wound site, regulated under 892.1710. It requires 510(k) clearance and falls within the radiology medical specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- POY
- Device Class
- FDA class 2
- Regulation Number
- 892.1710
- Medical Specialty
- Radiology
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
To achieve and maintain hemostasis of a breast biopsy wound site.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K163388 | XPress BCD Breast Compression Device | Jul 19, 2017 | Substantially Equivalent | Xpress Bcd, LLC |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.