# K241523: injeTAK Adjustable Tip Needle (DIS199; DIS201)

- Pathway: 510(k) (Special)
- Applicant: Laborie Medical Technologies, Corp.
- Decided: Aug 27, 2024 after 90 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: 6 generations back to K820973 (1982). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090830: Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip, Laborie Medical Technologies, Ltd. (2009) Summary page 5.

## Indications for use
The injeTAK Adjustable Tip Needles are intended to be used to deliver a variety of legally marketed drugs into tissues or structures during cystoscopic procedures. They are provided sterile for single use only.

Source page: https://510kreport.com/device/K241523
Methodology: https://510kreport.com/methodology