# K160423: Perineologic Access Needle

- Pathway: 510(k) (Traditional)
- Applicant: Corbin Clinical Resources, LLC
- Decided: Sep 2, 2016 after 199 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: 3 generations back to K904987 (1991). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936194: Coaxial Biopsy Needle, Bard Gynecology and Radiology (1994) Summary page 5.
- K140137: Safety Biopsy Needle System, Pfm Medical, Inc. (2014) Summary page 5.

## Most influential descendants
- 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 Perineologic Access Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissue and tumors of such organs as liver, kidney, spleen, lymph nodes, prostate, lung and various soft tissue lesions.

Source page: https://510kreport.com/device/K160423
Methodology: https://510kreport.com/methodology