Cleared Traditional

K213683 - Promisemed Fine Biopsy Needle

K213683 is an FDA 510(k) clearance for Promisemed Fine Biopsy Needle, manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code KNW cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K213683 · Promisemed Hangzhou Meditech Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
151d
Days
Class 2
Risk

K213683 is an FDA 510(k) clearance for the Promisemed Fine Biopsy Needle. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on April 22, 2022 after a review of 151 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 Promisemed Hangzhou Meditech Co., Ltd. devices

FDA 510(k) Submission Details - K213683

510(k) Number K213683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2021
Decision Date April 22, 2022
Days to Decision 151 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
36d slower than avg
Panel avg: 115d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

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 290
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K213683.
Disposable Semi Automatic Biopsy Instrument
K212820 · Suzhou Leapmed Healthcare Corporation · Jul 2022
NovaCore Semi-Automatic Biopsy Instrument
K213232 · Argon Medical Devices · Jul 2022
Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle
K214063 · Guangzhou Shengwei Medical Devices Co., Ltd. · Jun 2022
BD Trek Powered Bone Biopsy System
K213896 · Bard Peripheral Vascular · Mar 2022
TeesuVac Breast Biopsy Device Mark 1
K212079 · Teesuvac Aps · Feb 2022
Arthrex Vortex Threaded Bone Marrow Recovery Needle
K213213 · Arthrex, Inc. · Nov 2021