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FDA 510(k)

TeesuVac Breast Biopsy Device Mark 1

K-Number: K212079 · 2022-02-02

ApplicantTeesuvac Aps
Decision Date2022-02-02
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TeesuVac Breast Biopsy Device Mark 1 is a medical device manufactured by Teesuvac Aps. It received FDA 510(k) clearance on 2022-02-02 under approval number K212079. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TeesuVac Breast Biopsy Device Mark 1?

TeesuVac Breast Biopsy Device Mark 1 is a medical device that received FDA 510(k) clearance on 2022-02-02. It is manufactured by Teesuvac Aps. The 510(k) number is K212079.

When was TeesuVac Breast Biopsy Device Mark 1 approved by the FDA?

TeesuVac Breast Biopsy Device Mark 1 received FDA 510(k) clearance on 2022-02-02, under approval number K212079.

What company makes TeesuVac Breast Biopsy Device Mark 1?

TeesuVac Breast Biopsy Device Mark 1 is manufactured by Teesuvac Aps.

What is the FDA product code for TeesuVac Breast Biopsy Device Mark 1?

The FDA product code for TeesuVac Breast Biopsy Device Mark 1 is KNW.

Related Clinical Trials

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026)

Related Devices (Code: KNW)

K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer NeedlesM.D.L. S.R.L. K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer StyletDevicor Medical Products, Inc. K161234CASSI II Rotational Core Biopsy SystemScion Medical Technologies, LLC K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemMermaid Medical A/S K161805EnCor MRI Introducer Set, EnCor Probe IntroducerSenorx, Inc. K153337Corvocet Biopsy SystemMerit Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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