# K983200: Injection/Aspiration Needles Probes/Devices-Tpi/Tpi Flex

- Pathway: 510(k) (Traditional)
- Applicant: Ximed/Prosure/Injectx
- Decided: Dec 11, 1998 after 88 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K102274: Arvik Laparoscopic Aspiration Instrument (2011), 0 descendants of its own

## Indications for use
The Injection/ Aspiration probes and devices are to be used independently or with commercially available rigid and flexible endoscopes, including laparoscopes, hysteroscopes, cystoscopes, resectoscopes, and suction/ irrigation systems. These devices can be used for laparoscopic, ysteroscopxc, cystoscopic, and other endoscopic and open surgical procedures designed for injection and aspiration of fluids and solutions in the tissue or body. This device is not “intended for injection of drugs.

Source page: https://510kreport.com/device/K983200
Methodology: https://510kreport.com/methodology