Product code POY— Radiology

XPress BCD Breast Compression Device

Classification name: Post Breast Biopsy Hemostatic Breast Compression Device
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Total cleared: 1
First cleared: 2017-07-19
Most recent: 2017-07-19

FDA classification definition

“To achieve and maintain hemostasis of a breast biopsy wound site.”
— U.S. Food and Drug Administration, device classification record for product code POY under 21 CFR 892.1710, via openFDA

Market context for product code POY

FDA has cleared 1 device under product code POY, all in 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code POY

Xpress Bcd, LLC1 clearance

Recent clearances under product code POY

K163388 — XPress BCD Breast Compression DeviceXpress Bcd, LLC·2017-07-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.