Manufacturer
Karl Storz SE & CO. KGKARL STORZ Urological Laser Accessories
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
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Not ingested
K230535 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K230535 as a predicate