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FDA 510(k)

BEXCORE Breast Biopsy System, Biopsy Needle

K-Number: K171890 · 2018-08-20

ApplicantMedical Park Co., Ltd.
Decision Date2018-08-20
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BEXCORE Breast Biopsy System, Biopsy Needle is a medical device manufactured by Medical Park Co., Ltd.. It received FDA 510(k) clearance on 2018-08-20 under approval number K171890. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEXCORE Breast Biopsy System, Biopsy Needle?

BEXCORE Breast Biopsy System, Biopsy Needle is a medical device that received FDA 510(k) clearance on 2018-08-20. It is manufactured by Medical Park Co., Ltd.. The 510(k) number is K171890.

When was BEXCORE Breast Biopsy System, Biopsy Needle approved by the FDA?

BEXCORE Breast Biopsy System, Biopsy Needle received FDA 510(k) clearance on 2018-08-20, under approval number K171890.

What company makes BEXCORE Breast Biopsy System, Biopsy Needle?

BEXCORE Breast Biopsy System, Biopsy Needle is manufactured by Medical Park Co., Ltd..

What is the FDA product code for BEXCORE Breast Biopsy System, Biopsy Needle?

The FDA product code for BEXCORE Breast Biopsy System, Biopsy Needle is KNW.

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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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