# K011270: Automated Core Biopsy Device

- Pathway: 510(k) (Traditional)
- Applicant: Promex, Inc.
- Decided: Jun 22, 2001 after 57 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
No predicates in its family tree.
6 later devices descend from it; 2 cite 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K111765: Full Core Biopsy System (2011), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K011270
Methodology: https://510kreport.com/methodology