# K982905: MVM 7.5 French Flexible Ureteroscope

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy
- Decided: Oct 5, 1998 after 48 days
- Product code: FGB (Ureteroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K232911: KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1) (2024), 0 descendants of its own

## Recalls of this device
- Apr 1, 2022 · Class II · Z-1067-2022: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

## Indications for use
This instrument is indicated for examination of the upper urinary tract including the ureter and kidneys and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K982905
Methodology: https://510kreport.com/methodology