# K962172: Flexible Mini-Fiberscopes

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Dec 2, 1996 after 180 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.
8 later devices descend from it; 2 cite it directly.
0 of 9 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 its predicate without a number.
- (no number) Circon ACMI Model AUR-8: named in the summary without a submission number
- (no number) Circon ACMI Model AUR-9: named in the summary without a submission number
- (no number) Circon ACMI Model AUR-PN: named in the summary without a submission number
- (no number) Karl Storz Model 11274AA: named in the summary without a submission number
- (no number) Olympus Model PF-28: named in the summary without a submission number
- (no number) Olympus Model URF-P2: named in the summary without a submission number

## Most influential descendants
- K980401: Flexible Fiberscopes and Accessories (1998), 6 descendants of its own
- 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

## Indications for use
The flexible mini-fiberscopes are intended to be used in various Gastroenterology/Urology Procedures. These uses are: 1) Cystoscope - Used to examine the urinary tract, and, using additional accessories, to perform various diagnostic and therapeutic procedures. 2) Choledochoscope - Used to examine the bile ducts, and using, additional accessories, to perform various diagnostic and therapeutic procedures. 3) Ureteroscope - Used to examine the ureter, and using additional accessories, to perform various diagnostic and therapeutic procedure. 4) Nephroscope - Used to examine the kidney, and with additional accessories, to perform various diagnostic and therapeutic accessories. 5) Uretero-renoscope - Used to examine the ureter and kidney, and additional accessories, to perform various diagnostic and therapeutic procedures. Accessory Indications for use. 6) Flexible Biopsy Forceps - Used to obtain small biopsies from tissue. 7) Flexible Grasping Forceps - For grasping calculi, both renal and biliary. 8) Button Electrode - Used for unipolar coagqulation. 9) Dormia Stone Extractor - Used for grasping and removal of calculi, both renal and biliary. 10) Three Pronged Grasper - Used for grasping and removal of calculi, both renal and biliary.

Source page: https://510kreport.com/device/K962172
Methodology: https://510kreport.com/methodology