# K915801: Bip-Coax-System

- Pathway: 510(k) (Traditional)
- Applicant: Uni-Quatro Industries Canada, Inc.
- Decided: Mar 11, 1994 after 808 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- 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/K915801
Methodology: https://510kreport.com/methodology