# K183171: ScopeSeal Duodenoscope Protective Device

- Pathway: 510(k) (Traditional)
- Applicant: Gi Scientific, LLC
- Decided: Oct 8, 2019 after 326 days
- Product code: ODB (Endoscopic Contamination Prevention Sheath)
- 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: 7 generations back to K921244 (1992). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100966: Colonoscope/Sigmoidoscope Sheathes, Sheathing Technologies, Inc. (2010) Summary page 4.

## Indications for use
When properly installed: (i) the ScopeSeal® Duodenoscope Protective Device acts as a protective barrier at the scope’s distal end to significantly reduce the level of contamination of the distal end during use and prior to reprocessing, and (ii) the ScopeSeal®’s working channel also provides a protective barrier sealing the duodenoscope’s elevator area during use, and (iii) the ScopeSeal® device provides an additional protective benefit after use when kept in place during the ScopeSeal Pre-Cleaning Procedure™ performed after use. The ScopeSeal® is compatible for use with the Olympus Duodenoscope Model TIF-Q180V.

Source page: https://510kreport.com/device/K183171
Methodology: https://510kreport.com/methodology