# K100966: Colonoscope/Sigmoidoscope Sheathes

- Pathway: 510(k) (Traditional)
- Applicant: Sheathing Technologies, Inc.
- Decided: Aug 3, 2010 after 117 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: 6 generations back to K921244 (1992). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081004: Protectiscope CS Colonoscope, Non-Intrapull, Stryker GI (2008). Our reading of the summary gave K051004, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ProtectiScope colonoscope Sheath”.
- K032688: Colonosight Model 510B, Sightline Technologies, Ltd. (2004) Summary page 2.

## Most influential descendants
- K183171: ScopeSeal Duodenoscope Protective Device (2019), 0 descendants of its own

## Indications for use
Colonoscope/Sigmoidoscope Sheaths are meant for use in non-sterile colonoscopy or sigmoidoscopy procedures to help reduce gross contamination of the endoscope, reducing the exposure of staff to gross contamination during the cleaning procedure.

Source page: https://510kreport.com/device/K100966
Methodology: https://510kreport.com/methodology