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FDA 510(k)

Biopsy Needle

K-Number: K191472 · 2020-01-29

ApplicantUshare Medical, Inc.
Decision Date2020-01-29
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Biopsy Needle is a medical device manufactured by Ushare Medical, Inc.. It received FDA 510(k) clearance on 2020-01-29 under approval number K191472. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biopsy Needle?

Biopsy Needle is a medical device that received FDA 510(k) clearance on 2020-01-29. It is manufactured by Ushare Medical, Inc.. The 510(k) number is K191472.

When was Biopsy Needle approved by the FDA?

Biopsy Needle received FDA 510(k) clearance on 2020-01-29, under approval number K191472.

What company makes Biopsy Needle?

Biopsy Needle is manufactured by Ushare Medical, Inc..

What is the FDA product code for Biopsy Needle?

The FDA product code for Biopsy Needle is FCG.

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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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