510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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POYClass II

Post Breast Biopsy Hemostatic Breast Compression Device

21 CFR 892.1710 / Radiology
FDA source (opens on fda.gov)

POY is the FDA product code for Post Breast Biopsy Hemostatic Breast Compression Device, a class II device type, regulated under 21 CFR 892.1710. FDA's definition for this code reads: "To achieve and maintain hemostasis of a breast biopsy wound site". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
POY
Device name
Post Breast Biopsy Hemostatic Breast Compression Device
FDA definition
To achieve and maintain hemostasis of a breast biopsy wound site.
Regulation
21 CFR 892.1710
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code POY

By decision year
1 clearance under product code POY with a decision year between 2017 and 2017, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code POY by decision year
YearClearances
20171

Applicants with the most clearances

Product code POY
Applicants holding the most 510(k) clearances under product code POY
ApplicantClearances
Xpress BCD LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code