# K971842: Coaxial Needle

- Pathway: 510(k) (Traditional)
- Applicant: United States Endoscopy Group, Inc.
- Decided: Jun 20, 1997 after 32 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.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K012864: Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836 (2001), 9 descendants of its own
- K171454: Interject Injection Therapy Needle Catheter (2017), 7 descendants of its own
- K190032: Disposable Sclerotherapy Needle (2020), 3 descendants of its own
- K220292: Disposable Endoscope Injection Needle (2022), 1 descendant of its own
- K212668: Sclerotherapy Needle (2022), 1 descendant of its own

## Recalls of this device
- May 18, 2016 · Class II · Z-0289-2017: US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal ca

## Indications for use
The Coaxial Needle is used for endoscopic injection to control bleeding or lift sessile polyps using various media. An irrigation tube or syringe may be attached to the aspiration port of the needle in order to flush the injection site for better visualization.

Source page: https://510kreport.com/device/K971842
Methodology: https://510kreport.com/methodology