Cleared Traditional

TeesuVac Breast Biopsy Device Mark 1 (K212079) - FDA 510(k) Clearance

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

K212079 · Teesuvac Aps · General & Plastic Surgery device
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Feb 2022
Decision
215d
Days
Class 2
Risk

K212079 is an FDA 510(k) clearance for the TeesuVac Breast Biopsy Device Mark 1. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Teesuvac Aps (Hoersholm, DK). The FDA issued a Cleared decision on February 2, 2022 after a review of 215 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 Teesuvac Aps devices

Submission Details

510(k) Number K212079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2021
Decision Date February 02, 2022
Days to Decision 215 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
100d slower than avg
Panel avg: 115d · This submission: 215d
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 K212079.
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
Promisemed Fine Biopsy Needle
K213683 · Promisemed Hangzhou Meditech Co., Ltd. · Apr 2022
BD Trek Powered Bone Biopsy System
K213896 · Bard Peripheral Vascular · Mar 2022
Arthrex Vortex Threaded Bone Marrow Recovery Needle
K213213 · Arthrex, Inc. · Nov 2021
Disposable Automatic Core Biopsy Instrument
K212284 · Suzhou Leapmed Healthcare Corporation · Nov 2021
Uramix CuraWay Biopsy Needle
K203141 · Uramix, Inc. · Sep 2021