# K043383: N-DO Endoinjector Needle, Model PH00961109 and PH00961110

- Pathway: 510(k) (Traditional)
- Applicant: Physion, Inc.
- Decided: Oct 27, 2005 after 322 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K090830: Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip (2009), 3 descendants of its own
- 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

## Indications for use
The N-DO Endoinjector Needles are intended to deliver a variety of legally marketed materials into the urethra, prostate and vesical cavities with visualization via a cystoscope.

Source page: https://510kreport.com/device/K043383
Methodology: https://510kreport.com/methodology