# K230535: KARL STORZ Urological Laser Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: Sep 8, 2023 after 193 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 K942786 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942786: Karl Storz Laser Accessories, KARL STORZ Endoscopy-America, Inc. (1994) Summary page 5.

## Indications for use
The KARL STORZ Urological Laser Accessories are used with laser fibers during urological endoscopic procedures. The above indications are applicable to the following model numbers: 27026 VA 27026 VI 27026 VIL 27026 OV 27026 VS 27040 SL 27040 SD 27050 SL 27050 SC 27040 XA 27040 XAL PV27040 XAL-1 27050 CA 27050 XA 27056 LA 27056 LB 27056 LE 27056 EA 27056 EB 27056 EC 27056 ED 27068 CD 27050 VL 27040 OC 27048 CK 27050 BE 27050 BK 27051 B 27500 27502 27026 VY

Source page: https://510kreport.com/device/K230535
Methodology: https://510kreport.com/methodology