Cleared Traditional

K212822 - Disposable Coaxial Biopsy Needle (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
192d slower than avg
Panel avg: 114d · This submission: 306d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 132
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K212822.
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
K252646 · Olympus Medical Systems Corp. · Oct 2025
ClearTip FNA and FNB Types
K250994 · Finemedix Co., Ltd. · Aug 2025
EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)
K241209 · Cook Ireland, Ltd. · Jul 2024
Precision GI
K231422 · Limaca Medical, Ltd. · Aug 2023
ClearTip
K231267 · Finemedix Co., Ltd. · Jun 2023
EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
K230909 · Cook Ireland, Ltd. · May 2023