# K945185: Cystoscope (78FAJ)Endoscope,Fiberoptic (78GDB)

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: May 3, 1995 after 191 days
- Product code: FBO (Cystourethroscope)
- 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K131364: Flexible Cmos-Video-Cysto-Urethroscope (2014), 4 descendants of its own
- K182723: Flexible HD Cysto-Urethroscope System (2019), 3 descendants of its own
- K191357: Flexible HD Cysto-Urethroscope System (2019), 2 descendants of its own
- K202957: Flexible Video Cysto-Urethroscope (C-view) (2020), 1 descendant of its own
- K244001: KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) (2025), 0 descendants of its own

## Recalls of this device
- Apr 1, 2022 · Class II · Z-1061-2022: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

Source page: https://510kreport.com/device/K945185
Methodology: https://510kreport.com/methodology