# K090830: Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip

- Pathway: 510(k) (Traditional)
- Applicant: Laborie Medical Technologies, Ltd.
- Decided: Jul 21, 2009 after 117 days
- Product code: FBK (Endoscopic Injection Needle, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K820973 (1982). 10 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043383: N-DO Endoinjector Needle, Model PH00961109 and PH00961110, Physion, Inc. (2005) Summary page 1.
- K022484: Cook Injection Needle, Cook Urological, Inc. (2002) Summary page 1.

## Most influential descendants
- K180214: Repris Bladder Injection System (2018), 1 descendant of its own
- K253598: InjecSURE Injection System (2026), 0 descendants of its own
- K241523: injeTAK Adjustable Tip Needle (DIS199; DIS201) (2024), 0 descendants of its own

## Recalls of this device
- Feb 7, 2023 · Class II · Z-1478-2023: The packaging may be damaged, compromising the sterile barrier.

## Indications for use
The injeTak TM 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 and single use only.

Source page: https://510kreport.com/device/K090830
Methodology: https://510kreport.com/methodology