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FDA 510(k)

Disposable Biopsy Refill Needle

K-Number: K212819 · 2022-07-06

ApplicantSuzhou Leapmed Healthcare Corporation
Decision Date2022-07-06
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Biopsy Refill Needle is a medical device manufactured by Suzhou Leapmed Healthcare Corporation. It received FDA 510(k) clearance on 2022-07-06 under approval number K212819. 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 Disposable Biopsy Refill Needle?

Disposable Biopsy Refill Needle is a medical device that received FDA 510(k) clearance on 2022-07-06. It is manufactured by Suzhou Leapmed Healthcare Corporation. The 510(k) number is K212819.

When was Disposable Biopsy Refill Needle approved by the FDA?

Disposable Biopsy Refill Needle received FDA 510(k) clearance on 2022-07-06, under approval number K212819.

What company makes Disposable Biopsy Refill Needle?

Disposable Biopsy Refill Needle is manufactured by Suzhou Leapmed Healthcare Corporation.

What is the FDA product code for Disposable Biopsy Refill Needle?

The FDA product code for Disposable Biopsy Refill Needle is FCG.

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Other Devices by Suzhou Leapmed Healthcare Corporation

K212284Disposable Automatic Core Biopsy Instrument K212822Disposable Coaxial Biopsy Needle K212820Disposable Semi Automatic Biopsy Instrument

Related Devices (Code: 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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