# K072521: Cook Fiber Optic Bundle and Flexor Deflecting Access Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Nov 20, 2007 after 74 days
- Product code: FFS (Image, Illumination, Fiberoptic, For Endoscope )
- 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
Longest line of descent: 3 generations back to K990775 (1999). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925128: The Karl Storz 11274 Series Flexible Fiberscope, KARL STORZ Endoscopy-America, Inc. (1993) Summary page 1.
- K922826: Flexible Fiber Optic Endoscope, Optimed Technologies, Inc. (1993) Summary page 1.
- K043418: Cook Pediatric Flexor Ureteral Access Shealth, Cook Urological, Inc. (2005) Summary page 1.
- K030642: Deflecting Ureteral Access Sheath, Applied Medical Resources Corp. (2003) Summary page 1.

## Recalls of this device
- May 3, 2017 · Class II · Z-2540-2017: Cook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor Vue Deflecting Endoscopic System because it was determined that the current reprocessing instructions do

## Indications for use
The Cook®Fiber Optic Bundle and Flexor® Deflecting Access Sheath are intended for use during cystoscopic, nephroscopic, laparoscopic and ureteroscopic procedures. The Cook® Fiber Optic Bundle is intended for direct visualization of body cavities or organs. The Flexor® Deflecting Access Sheath is used to provide access as well as protection for the Cook® Fiber Optic Bundle and has a second working channel for passage of additional instrumentation.

Source page: https://510kreport.com/device/K072521
Methodology: https://510kreport.com/methodology