# K111765: Full Core Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Promex Technologies, LLC
- Decided: Sep 6, 2011 after 75 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 K904987 (1991). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011270: Automated Core Biopsy Device, Promex, Inc. (2001) Summary page 1.
- K904987: Vibronics Auto Core Biopsy Device (Acbd), Vibronics (1991) Summary page 1.

## Most influential descendants
- K140137: Safety Biopsy Needle System (2014), 3 descendants of its own
- K160423: Perineologic Access Needle (2016), 2 descendants of its own
- K210946: Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles (2021), 1 descendant of its own
- K261196: Promisemed VeriEcto Automatic Biopsy Needles (2026), 0 descendants of its own

## Indications for use
The Full Core Biopsy System is intended to be used for soft tissue and tumor biopsy 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 of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of 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 of using standard surgical procedures.

Source page: https://510kreport.com/device/K111765
Methodology: https://510kreport.com/methodology