# K022655: Trimedyne Side Firing Needle with Vent Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Trimedyne, Inc.
- Decided: Nov 7, 2002 after 90 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K963969 (1997). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992230: Omnitip Side Firing Switchable Tip with Suction/Irrigation, Model 20371-HP, Trimedyne, Inc. (1999) Summary page 1.
- K010041: SLT Diffuser Fiber, Surgical Laser Technologies, Inc. (2001) Summary page 1.
- K990851: Indigo Laseroptic Treatment System, Indigo Medical, Inc. (1999) Summary page 1.

## Most influential descendants
- K050412: Vapormax (2005), 2 descendants of its own
- K053457: Vapormax II (2005), 1 descendant of its own
- K233157: VaporMAX LDD; MOJo LDD; MegaJOULE LDD (2024), 0 descendants of its own

## Indications for use
Superficial and interstitial incision, excision, ablation, vaporization, and coagulation.

Source page: https://510kreport.com/device/K022655
Methodology: https://510kreport.com/methodology