# K150088: Evacore Fully Disposable Vacuum Assist Biopsy Device

- Pathway: 510(k) (Traditional)
- Applicant: Pin-Point Care Corp.
- Decided: Jul 20, 2015 after 185 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: 1 generation back to K034021 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034021: Vacuum Assisted Core Biopsy Device, Suros Surgical Systems, Inc. (2004) Summary page 4.

## Indications for use
To obtain percutaneous core biopsy samples from soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, lung, breast. and lymph nodes. When used for breast biopsy, the product is for diagnosis only. The extent histological abnormality in breast tissue cannot be reliably determined from mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not guarantee the complete removal of the affected tissue. When the sampled abnormality is not benign, it is necessary that the tissue margins be examined to ensure that the area of suspicion (e.g., malignancy) has been completely removed using standard surgical procedures.

Source page: https://510kreport.com/device/K150088
Methodology: https://510kreport.com/methodology