# K163197: Cook Holmium Laser Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: May 24, 2017 after 190 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: 23 generations back to K943450 (1995). 404 ancestors in all.
No later device cites it as a predicate yet.
0 of 405 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124030: Cook Holmium Laser Fiber, Cook Incorporated (2013) Summary page 4.
- K131473: (Quanta System) Surgical Laser Fibers, Quanta System Spa (2013) Summary page 4.

## Indications for use
Intended for stone fragmentation, incision, excision, ablation, coagulation (hemostasis) when attached to the H-30 Holmium Laser System or Odyssey Holmium Laser System for the indications for which the lasers have been cleared.

Source page: https://510kreport.com/device/K163197
Methodology: https://510kreport.com/methodology