# K965180: Straightfire Reusable Optical Fibers (400,600,800,1000)

- Pathway: 510(k) (Traditional)
- Applicant: Myriad Lase, Inc.
- Decided: Jun 5, 1997 after 163 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: 1 generation back to K914396 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920553: Myriadlase Sidefire-Tipped Optical Fiber, Myriad Lase, Inc. (1992) Summary page 1.
- K952733: Sidefire - Tipped Reusable Optical Fibers, Myriad Lase, Inc. (1995) Summary page 1.
- K914396: Surgi Light Non-Contact Fibers, Lifestream Int'L, Inc. (1991) Summary page 1.

## Indications for use
Ablation and hemostasis in treatment of gynecological and urological conditions, as well as multiple applications in gastroenterology and general surgery.

Source page: https://510kreport.com/device/K965180
Methodology: https://510kreport.com/methodology