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FDA 510(k)

XPress BCD Breast Compression Device

K-Number: K163388 · 2017-07-19

ApplicantXpress Bcd, LLC
Decision Date2017-07-19
Product CodePOY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XPress BCD Breast Compression Device is a medical device manufactured by Xpress Bcd, LLC. It received FDA 510(k) clearance on 2017-07-19 under approval number K163388. The device is classified under product code POY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XPress BCD Breast Compression Device?

XPress BCD Breast Compression Device is a medical device that received FDA 510(k) clearance on 2017-07-19. It is manufactured by Xpress Bcd, LLC. The 510(k) number is K163388.

When was XPress BCD Breast Compression Device approved by the FDA?

XPress BCD Breast Compression Device received FDA 510(k) clearance on 2017-07-19, under approval number K163388.

What company makes XPress BCD Breast Compression Device?

XPress BCD Breast Compression Device is manufactured by Xpress Bcd, LLC.

What is the FDA product code for XPress BCD Breast Compression Device?

The FDA product code for XPress BCD Breast Compression Device is POY.

Related Clinical Trials

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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