Cleared Traditional

K212822 - Disposable Coaxial Biopsy Needle

K212822 is an FDA 510(k) clearance for Disposable Coaxial Biopsy Needle, manufactured by Suzhou Leapmed Healthcare Corporation. The device is a Class 2 General & Plastic Surgery device with product code FCG cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K212822 · Suzhou Leapmed Healthcare Corporation · General & Plastic Surgery device
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Jul 2022
Decision
306d
Days
Class 2
Risk

K212822 is an FDA 510(k) clearance for the Disposable Coaxial Biopsy Needle. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Suzhou Leapmed Healthcare Corporation (Suzhou, CN). The FDA issued a Cleared decision on July 6, 2022 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1075 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Suzhou Leapmed Healthcare Corporation devices

FDA 510(k) Submission Details - K212822

510(k) Number K212822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2021
Decision Date July 06, 2022
Days to Decision 306 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
191d slower than avg
Panel avg: 115d · This submission: 306d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCG Device Classification - Class 2, Special Controls

Product Code FCG Biopsy Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Shanghai Truthful Information Technology Co., Ltd.
Boyle Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FCG Biopsy Needle

All 55
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K212822.
EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
K230909 · Cook Ireland, Ltd. · May 2023
EndoDrill® Model X
K212423 · Bibbinstruments AB · Mar 2023
Disposable Biopsy Refill Needle
K212819 · Suzhou Leapmed Healthcare Corporation · Jul 2022
EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle
K210476 · Cook Ireland, Ltd. · May 2021
Biopsy Needle
K191472 · Ushare Medical, Inc. · Jan 2020
Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
K181756 · Apriomed AB · Dec 2018