# K212079: TeesuVac Breast Biopsy Device Mark 1

- Pathway: 510(k) (Traditional)
- Applicant: Teesuvac Aps
- Decided: Feb 2, 2022 after 215 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922939 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133948: Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable Core Instrument, Bard Peripheral Vascular, Inc. (2014) Summary page 5.

## Indications for use
The TeesuVac Breast Biopsy Device Mark 1 is indicated to obtain percutaneous core biopsy specimens from soft tissue, and tumors of the breast. This product is intended for diagnostic use only, NOT therapeutic therapy. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removing the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Source page: https://510kreport.com/device/K212079
Methodology: https://510kreport.com/methodology