# K994151: Percutx-Injection/Aspiration Needle Probes/Devices

- Pathway: 510(k) (Traditional)
- Applicant: Ximed/Prosure/Injectx
- Decided: Mar 1, 2000 after 83 days
- Product code: GAA (Needle, Aspiration And Injection, Disposable)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
51 later devices descend from it; 2 cite it directly.
1 of 52 devices in its family (counting itself) has 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
- K083330: Echotip Ultra Ultrasound Needle (2009), 49 descendants of its own
- K092359: Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A (2009), 16 descendants of its own
- K123676: Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes (2013), 11 descendants of its own
- K132389: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked (2014), 10 descendants of its own
- K111895: Echotip (R) Ultra Fiducial Needle (2012), 10 descendants of its own

## Indications for use
The PercuTx — Injection /Aspiration Needle device is indicated for use as an accessory for currently marketed endoscopes.to provide for delivery of injectable materials into tissues during endoscopic procedures. As with currently marketed endoscopic injection needles, the PercuTx Endoscopic Injection needle device may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials which have received approval for use by the FDA. The type of material to be injected will be dependent on the nature of the endoscopic procedure, but such materials may include for example: delivery of collagen during cystoscopic procedures; delivery of sclerosing agents during esophagoscopic, and gastroscopic procedures; delivery of local anesthetics during cystoscopic or laryngoscopic procedures; or delivery of saline or contrast media during colonoscopic.

Source page: https://510kreport.com/device/K994151
Methodology: https://510kreport.com/methodology