# K980401: Flexible Fiberscopes and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: May 21, 1998 after 108 days
- Product code: FAJ (Cystoscope 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
Longest line of descent: 1 generation back to K962172 (1996). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962172: Flexible Mini-Fiberscopes, Richard Wolf Medical Instruments Corp. (1996) Summary page 1.
- (no number) Flexible CystoNephroscope ACN: named in the summary without a submission number
- (no number) Flexible Hysteroscope, AUR-FH: named in the summary without a submission number
- (no number) Cysto-Urethro-Fiberscope 11272 AA: named in the summary without a submission number
- (no number) Flexible Hysteroscope, 11261 BB: named in the summary without a submission number
- (no number) Flexible Cystofiberscope CYF-3: named in the summary without a submission number
- (no number) Hysterofiberscope, HYF-1T: named in the summary without a submission number

## Most influential descendants
- K992526: Flexible Nasopharyngo-Laryngoscopes, Flexible Bronchoscope (1999), 3 descendants of its own
- K132039: Ergo-Flex Laryngo-Nasopharyngoscope EF-N and EF-N Slim (2014), 1 descendant of its own
- K150248: ORL Video NasoPharyngo-Larngoscope (2015), 0 descendants of its own
- K070580: Nasopharyngoscope, Bronchoscope (2007), 0 descendants of its own
- K051176: Flexible Video Cystoscope/Choledochoscope, Models 7308.061 and 7308.066 (2005), 0 descendants of its own

## Indications for use
For examination, diagnosis and/or therapy in connection with endoscopic accessories and auxiliary instruments used through the working channel of the instrument for use in urology, surgery, and GYN.

Source page: https://510kreport.com/device/K980401
Methodology: https://510kreport.com/methodology