# K081004: Protectiscope CS Colonoscope, Non-Intrapull

- Pathway: 510(k) (Special)
- Applicant: Stryker GI
- Decided: May 2, 2008 after 24 days
- Product code: FDF (Colonoscope 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: 5 generations back to K921244 (1992). 21 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032688: Colonosight Model 510B, Sightline Technologies, Ltd. (2004) Summary page 2.

## Most influential descendants
- K120289: Peerscope System (2012), 6 descendants of its own
- K130718: Peerscope System (2013), 5 descendants of its own
- K132839: Fuse 1C Colonoscopy System (2014), 2 descendants of its own
- K131422: Peerscope System (2013), 2 descendants of its own
- K152182: Fuse Gastroscopy System (2015), 1 descendant of its own

## Indications for use
Intended to provide visualization (via a video monitor) and therapeutic access to the lower gastrointestinal tract including, but not limited to the organs, tissues, and subsystems of the large bowel. The device is introduced rectally as with any standard colonoscope, when indications consistent with the requirement for the procedure are observed in adult patient populations.

Source page: https://510kreport.com/device/K081004
Methodology: https://510kreport.com/methodology