# K233372: KARL STORZ Fiber Telescopes for Urology

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: Jul 25, 2024 after 297 days
- Product code: FGB (Ureteroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K940464 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940464: Karl Storz Uretero-Renoscope/Ureterscope, KARL STORZ Endoscopy-America, Inc. (1994) Summary page 4.

## Most influential descendants
- K253411: Miniature Telescope for Urology (27033AA) (2025), 0 descendants of its own

## Recalls of this device
- Dec 19, 2024 · Class II · Z-1052-2025: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Dec 19, 2024 · Class II · Z-1051-2025: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Dec 19, 2024 · Class II · Z-1053-2025: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Dec 19, 2024 · Class II · Z-1054-2025: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Dec 19, 2024 · Class II · Z-1055-2025: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Dec 19, 2024 · Class II · Z-1058-2025: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Dec 19, 2024 · Class II · Z-1059-2025: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Dec 19, 2024 · Class II · Z-1061-2025: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Dec 19, 2024 · Class II · Z-1056-2025: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Dec 19, 2024 · Class II · Z-1057-2025: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Dec 19, 2024 · Class II · Z-1060-2025: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Dec 19, 2024 · Class II · Z-1062-2025: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Dec 19, 2024 · Class II · Z-1063-2025: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Dec 19, 2024 · Class II · Z-1064-2025: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

## Indications for use
For devices (27033C, 27033CR, 27033D, 27033F, 27033CRO, 27033CO, 27033DO, 27001E, 27001G, 27001GH, 27001GF, 27014Y) The sheaths, obturators, and accessories when used with compatible endoscopes are intended to provide visualization and access to operative site during minimal invasive urological endoscopic procedures in adults and pediatrics. For telescopes (27000K, 27000L, 27010K, 27010L, 27002KP, 27030KA, 27030KB) The endoscopes are intended to provide visualization of the operative site during minimal invasive urological endoscopic procedures in adults and pediatrics. For telescopes (27001K, 27001L, 27002K, 27002L, 27003L, 27011K, 27011L) The endoscopes are intended to provide visualization of the operative site during minimal invasive urological endoscopic procedures in adults.

Source page: https://510kreport.com/device/K233372
Methodology: https://510kreport.com/methodology