# K971977: Ksea 15.5 FR. Flexible Choledocho-Fiberscope

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Aug 12, 1997 after 75 days
- Product code: FBN (Choledochoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
102 later devices descend from it; 1 cites it directly.
1 of 103 devices in its family (counting itself) has 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
- K023358: Usa Series Dur 8 Elite, Usa Series Dur 8, Models Dur 8E, Dur 8 (2003), 101 descendants of its own
- K060269: Acmi Dur-Digital Ureteroscope and Choledochoscope System (2006), 99 descendants of its own
- K131369: Flexible Video-Uretero-Renoscope System (2013), 53 descendants of its own
- K153049: LithoVue System (2015), 24 descendants of its own
- K172098: Medical Video Endoscope System (2017), 23 descendants of its own

## Indications for use
The 15.5 Fr. Flexible Choledocho-Fiberscope is indicated for examination of the gall bladder and bile duct, and, using additional accessories, to perform diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K971977
Methodology: https://510kreport.com/methodology