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FDA 510(k)

Disposable Coaxial Biopsy Needle

K-Number: K212822 · 2022-07-06

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

Device Summary

Disposable Coaxial Biopsy 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 K212822. 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 Coaxial Biopsy Needle?

Disposable Coaxial Biopsy 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 K212822.

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

Disposable Coaxial Biopsy Needle received FDA 510(k) clearance on 2022-07-06, under 510(k) number K212822.

Who is the listed applicant for Disposable Coaxial Biopsy 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 Coaxial Biopsy Needle?

The FDA product code for Disposable Coaxial Biopsy 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.

K212820Disposable Semi Automatic Biopsy InstrumentK212819Disposable Biopsy Refill NeedleK212284Disposable 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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