# K040961: Injector Needle/Snare

- Pathway: 510(k) (Traditional)
- Applicant: United States Endoscopy Group, Inc.
- Decided: Jul 8, 2004 after 86 days
- Product code: FDI (Snare, Flexible)
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K092090: Erbelift Hand Pump and Flexible Probe (2009), 13 descendants of its own
- K143306: ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe (2015), 12 descendants of its own
- K111495: Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-K (2011), 9 descendants of its own
- K150852: SIC 8000 (2015), 8 descendants of its own
- K171158: Single Use Electrosurgical knife (2017), 7 descendants of its own

## Indications for use
The dual lumen Injector Needle Share is indicated for use with an Olympus or Microvasive active cord for the injection of media for submucosal lift of polyps or other mucosal lesions, using diredt visualization, thmough a flexible endoscope, prior to electrosurgical excision arid for the infusion of fluid for clearing away the field of view, applying dye spray, clot removal, injection of hemostatic agents to control post-polypectomy bleeding, and tattooing of sites for future surgical purposes.

Source page: https://510kreport.com/device/K040961
Methodology: https://510kreport.com/methodology