# K183199: TRIO Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Omniguide, Inc.
- Decided: May 2, 2019 after 164 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: 6 generations back to K844002 (1984). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081939: Omniguide Beampath Fiber Optic Handpiece System and Sterilization Tray, Omniguide, Inc. (2008) Summary page 4.
- K962396: Ksea Bipolar Goagulating Forceps, KARL STORZ Endoscopy-America, Inc. (1996) Summary page 4.
- K960009: Storz S2050 Series Bipolar Forceps, Storz Instrument Co. (1996) Summary page 4.
- K965241: Bipolar Suction Coagulator, Kirwan Surgical Products, Inc. (1997) Summary page 4.
- K900533: Disposable Bipolar Coagulating Forceps, Kirwan Surgical Products, Inc. (1990) Summary page 4.

## Indications for use
The OmniGuide® TRIO™ handpiece is indicated for the electrosurgical coagulation of soft body tissues and suction of fluids in general and ENT surgical procedures for the specialties of General Surgery, Head and Neck Surgery, Otolaryngology, and Oral surgery (including intra-oral tissues). When used with the OmniGuide® BeamPath® Laser waveguide, it is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues for the added specialties of Dermatology, Gynecology, Neurosurgery, Orthopedic Surgery, Plastic & Reconstructive Surgery, Podiatry and Urology.

Source page: https://510kreport.com/device/K183199
Methodology: https://510kreport.com/methodology