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KARL STORZ Urological Laser Accessories

Karl Storz SE & CO. KG

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

Product code GEX· 21 CFR 878.4810

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Company

Karl Storz SE & CO. KG
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

1
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Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K230535
Device name
KARL STORZ Urological Laser Accessories
Company
Karl Storz SE & CO. KG
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-02-27
Decision date
2023-09-08
Submission type
Traditional
Technology type
Laser fiber / delivery(AI inferred)
Clinical applications
Surgical cuttingOther
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The KARL STORZ Urological Laser Accessories are used with laser fibers during urological endoscopic procedures.

Intended Use

The KARL STORZ Urological Laser Accessories are used with laser fibers during urological endoscopic procedures.

Device Description

KARL STORZ Urological Laser Accessories are manually operated reusable surgical devices that are used with a cystoscope for examination, diagnosis, and/or therapy in the Urology discipline. Urological Laser Accessories may consist of: Sheaths, Obturators, Working Elements, Telescope Bridges, Working Inserts, Guiding Probes, and Adaptors. A laser fiber may be inserted through the sheath channel for surgical tissue ablation.

Summary parsed at:2026-06-01 05:32:44 UTC

Predicate devices

1

K230535 references 1 predicate/reference device

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K230535 as a predicate