# K936194: Coaxial Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Bard Gynecology and Radiology
- Decided: Mar 22, 1994 after 83 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 3 (0 Class I)
- 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; 4 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 has not posted a summary or statement for it, so its predicates are not known.

## 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
- K181756: Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle (2018), 0 descendants of its own
- K151373: Corvocet Coaxial Introducer (2015), 0 descendants of its own

## Recalls of this device
- Jul 6, 2016 · Class II · Z-2547-2016: May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.
- Feb 4, 2016 · Class II · Z-1396-2016: Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles because they have the potential to have the incorrect sized blunt tip stylet within its packaging that will 
- May 1, 2006 · Not classified · Z-0913-06: Manufacturing change that has introduced variability in the length of the inner stylet. When the inner stylet length is inserted into the cannula component, the exposed stylet length may be up to 8mm 

Source page: https://510kreport.com/device/K936194
Methodology: https://510kreport.com/methodology