510(k) K163388
K163388 is an FDA 510(k) premarket notification submitted by Xpress Bcd, LLC for the device "XPress BCD Breast Compression Device". The FDA issued a decision of Substantially Equivalent on July 19, 2017. The device falls under product code POY (Post Breast Biopsy Hemostatic Breast Compression Device), a Class II device regulated under 21 CFR 892.1710.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2017
- Date Received
- December 2, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Post Breast Biopsy Hemostatic Breast Compression Device
- Device Class
- Class II
- Regulation Number
- 892.1710
- Review Panel
- SU
- Submission Type
To achieve and maintain hemostasis of a breast biopsy wound site.