Cleared Traditional

Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle (K214063) - FDA 510(k) Clearance

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

K214063 · Guangzhou Shengwei Medical Devices Co., Ltd. · General & Plastic Surgery device
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Jun 2022
Decision
158d
Days
Class 2
Risk

K214063 is an FDA 510(k) clearance for the Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, an.... Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Guangzhou Shengwei Medical Devices Co., Ltd. (Conghua City, CN). The FDA issued a Cleared decision on June 3, 2022 after a review of 158 days - an extended review cycle.

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. Standard predicate reliance. 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 Guangzhou Shengwei Medical Devices Co., Ltd. devices

Submission Details

510(k) Number K214063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2021
Decision Date June 03, 2022
Days to Decision 158 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
43d slower than avg
Panel avg: 115d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNW Instrument, Biopsy
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 Peers - KNW Instrument, Biopsy

All 105
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K214063.
NeoNavia Biopsy System
K220595 · Neodynamics AB · Sep 2022
Disposable Semi Automatic Biopsy Instrument
K212820 · Suzhou Leapmed Healthcare Corporation · Jul 2022
NovaCore Semi-Automatic Biopsy Instrument
K213232 · Argon Medical Devices · Jul 2022
Promisemed Fine Biopsy Needle
K213683 · Promisemed Hangzhou Meditech Co., Ltd. · Apr 2022
BD Trek Powered Bone Biopsy System
K213896 · Bard Peripheral Vascular · Mar 2022
TeesuVac Breast Biopsy Device Mark 1
K212079 · Teesuvac Aps · Feb 2022