Disposable Coaxial Biopsy Needle

FDA 510(k) K212822 · Suzhou Leapmed Healthcare Corporation

Substantially Equivalent

510(k) numberK212822

Submission

Device name
Disposable Coaxial Biopsy Needle
Applicant
Suzhou Leapmed Healthcare Corporation
Suzhou, CN
Received
September 3, 2021
Decision date
July 6, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FCG – Biopsy Needle
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1075
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FCG

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K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)FCG · Traditional Olympus Medical Systems Corp.10/24/2025SE
K250994ClearTip FNA and FNB TypesFCG · Traditional Finemedix Co., Ltd.08/21/2025SE
K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)FCG · Traditional Cook Ireland, Ltd.07/29/2024SE
K231422Precision GIFCG · Traditional Limaca Medical, Ltd.08/28/2023SE
K231267ClearTipFCG · Traditional Finemedix Co., Ltd.06/30/2023SE
K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)FCG · Traditional Cook Ireland, Ltd.05/30/2023SE
K212423EndoDrill® Model XFCG · Traditional Bibbinstruments AB03/29/2023SE
K212819Disposable Biopsy Refill NeedleFCG · Traditional Suzhou Leapmed Healthcare Corporation07/06/2022SE
K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…FCG · Traditional Cook Ireland, Ltd.05/20/2021SE
K191472Biopsy NeedleFCG · Traditional Ushare Medical, Inc.01/29/2020SE

More from Ushare Medical, Inc.

510(k)DeviceDecision
K212820Disposable Semi Automatic Biopsy InstrumentKNW · Traditional 07/06/2022SE
K212819Disposable Biopsy Refill NeedleFCG · Traditional 07/06/2022SE
K212284Disposable Automatic Core Biopsy InstrumentKNW · Traditional 11/10/2021SE

Questions and answers

When was Disposable Coaxial Biopsy Needle cleared by the FDA?

Disposable Coaxial Biopsy Needle (K212822) received a 510(k) decision of Substantially Equivalent on July 6, 2022, 306 days after the submission was received.

What is the product code of K212822?

The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.