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Cook Holmium Laser Fiber

Cook Incorporated

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Cook Incorporated
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
View list →

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K163197
Device name
Cook Holmium Laser Fiber
Company
Cook Incorporated
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-11-15
Decision date
2017-05-24
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Surgical cuttingAcne treatment
Primary application
Surgical cutting
Classification source
AI classified

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.

Intended 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.

Device Description

The Cook Holmium Laser Fibers are supplied sterile in peel-open packages. The multi-use fibers have a color coded connector to identify the four different fiber sizes, and will be sold individually. The single-use fibers have a red connector and come in four different sizes, and will be sold in boxes of three.

Summary parsed at:2026-06-01 05:59:17 UTC

Predicate devices

2

K163197 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K163197 as a predicate