# K992230: Omnitip Side Firing Switchable Tip with Suction/Irrigation, Model 20371-HP

- Pathway: 510(k) (Traditional)
- Applicant: Trimedyne, Inc.
- Decided: Jul 12, 1999 after 10 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
No predicates in its family tree.
4 later devices descend from it; 2 cite 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. The FDA summary names its predicate without a number.
- (no number) Trimedyne OmniTip™ Switchable Tips: named in the summary without a submission number
- (no number) Tapertip™ Holmium Arthroscopic Handpieces: named in the summary without a submission number

## Most influential descendants
- K022655: Trimedyne Side Firing Needle with Vent Sheath (2002), 3 descendants of its own
- 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
The OmniTip™ Side Firing Switchable Tip with Suction/Irrigation is intended for use with any pulsed Holmium:YAG 2.1 micrometer laser with a compatible connector for incision, excision, ablation, vaporization, and coagulation.

Source page: https://510kreport.com/device/K992230
Methodology: https://510kreport.com/methodology