# K080341: Endodrape (TM)

- Pathway: 510(k) (Abbreviated)
- Applicant: Vortek Surgical, LLC
- Decided: Jul 21, 2008 after 164 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K020581 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070406: Endodrape, Vortek Surgical, LLC (2007) Summary page 1.

## Indications for use
The intended use of the ENDODRAPE TM Upper Endoscopy Drape is to protect patients, staff and equipment from bodily secretions and to maintain a cleaner procedural site during non-sterile upper gastrointestinal endoscopic procedures. The device is a single use disposable drape that is provided non-sterile. The device can, however, be EtO (ethylene oxide) sterilized by the end user prior to use.

Source page: https://510kreport.com/device/K080341
Methodology: https://510kreport.com/methodology