# K140137: Safety Biopsy Needle System

- Pathway: 510(k) (Traditional)
- Applicant: Pfm Medical, Inc.
- Decided: Mar 25, 2014 after 62 days
- Product code: FCG (Biopsy Needle)
- 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 K904987 (1991). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111765: Full Core Biopsy System, Promex Technologies, LLC (2011) Summary page 1.
- K933364: Promed Biopsy Needle, Vlv Associates, Inc. (1994) Summary page 1.

## Most influential descendants
- 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 Safety Biopsy Needle System (Safety Biopsy Needle and Safety Coaxial Needle with Finger Guard) 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 far diagnosis only. The extent of histological abnormality cannot be reliably determined from its mamnmographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality; e.g., malignancy. When 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/K140137
Methodology: https://510kreport.com/methodology