# K983765: Injection Needle Probe/Device-Tunis

- Pathway: 510(k) (Traditional)
- Applicant: Ximed/Prosure/Injectx
- Decided: Dec 11, 1998 after 46 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.
13 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K022484: Cook Injection Needle (2002), 12 descendants of its own
- K090830: Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip (2009), 3 descendants of its own
- K090217: Bonee Needle for Bladder Injections, MODELSNBI035, NBI070 (2009), 2 descendants of its own
- K192498: Single Use Injector (2020), 1 descendant of its own
- K180214: Repris Bladder Injection System (2018), 1 descendant of its own

## Indications for use
The TUNIS™ probes and devices are to be used independently or with commerdially available rigid and flexible endoscopes, including laparoscopes, hysteroscopes, cystoscopes, resectoscopes for transurethral injection/aspua_hon procedures. The§e devices can be used for laparoscopic, hysteroscopic, cystoscopic, and other endoscopic & open surgical procedures designed for interstitial injection/aspiration of biomaterials, fluids and solutions in the urinary bladder and lower urinary ftract.

Source page: https://510kreport.com/device/K983765
Methodology: https://510kreport.com/methodology