# K050688: Tegress Implant Needle

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Apr 6, 2005 after 20 days
- Product code: FBK (Endoscopic Injection Needle, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001146 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001146: Genyx Flexible Injection Neeedle, Geny Medical, Inc. (2000)

## Indications for use
The Tegress TM Implant Needles are accessories for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.

Source page: https://510kreport.com/device/K050688
Methodology: https://510kreport.com/methodology