FDA product code POY: Post Breast Biopsy Hemostatic Breast Compression Device
POY is the FDA product code for post breast biopsy hemostatic breast compression device. It is a Class II device, regulated under 21 CFR 892.1710 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under POY. The average 510(k) review took 229 days (median 229).
Definition
To achieve and maintain hemostasis of a breast biopsy wound site.
Classification
| Field | Value |
|---|---|
| Device name | Post Breast Biopsy Hemostatic Breast Compression Device |
| Device class | Class II |
| Regulation | 21 CFR 892.1710 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for POY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 229 |
Compare with all 510(k) review times · Search every POY clearance
Top POY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Xpress Bcd, LLC | 1 | 2017-07-19 |
Most recent POY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K163388 | Xpress Bcd, LLC | XPress BCD Breast Compression Device | 2017-07-19 | 229 |
Recalls for POY devices
openFDA lists no recalls for product code POY.
Frequently asked questions
What is FDA product code POY?
POY is the FDA product code for post breast biopsy hemostatic breast compression device. It is a Class II device, regulated under 21 CFR 892.1710 and reviewed by the General and Plastic Surgery panel.
What device class is POY?
Class II, regulation 21 CFR 892.1710. Typical premarket route: 510(k).
How long does a 510(k) take for product code POY?
Across 1 cleared submissions the average was 229 days from receipt to decision (median 229).
Which companies have the most POY clearances?
Xpress Bcd, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code POY
- Run a recall and safety report across every POY manufacturer
- Watch product code POY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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