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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 the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Leapmed Healthcare Corporation. It received FDA 510(k) clearance on 2022-07-06 under 510(k) 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. The listed applicant is Suzhou Leapmed Healthcare Corporation. The 510(k) number is K212819.

When did Disposable Biopsy Refill Needle receive FDA 510(k) clearance?

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

Who is the listed applicant for Disposable Biopsy Refill Needle?

The FDA 510(k) record lists Suzhou Leapmed Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Suzhou Leapmed Healthcare Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212822Disposable Coaxial Biopsy NeedleK212820Disposable Semi Automatic Biopsy InstrumentK212284Disposable Automatic Core Biopsy Instrument

Related Devices (Code: FCG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.

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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