# K070406: Endodrape

- Pathway: 510(k) (Traditional)
- Applicant: Vortek Surgical, LLC
- Decided: Jul 30, 2007 after 168 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: 1 generation back to K020581 (2002). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050508: Hvo, Inc., Disposable Non-Sterile Surgical Drapes, Haywood Vocational Opportunities (2005) Summary page 2.
- K020581: Coloshield Colonoscopy Drape Model E2000, Medical Concepts Development, Inc. (2002) Summary page 2.

## Most influential descendants
- K080341: Endodrape (TM) (2008), 0 descendants of its own

## Indications for use
The intended use of the EndodrapeTM surgical and diagnostic procedure drape manufactured by Vortek Surgical is for patients receiving and/or medical professionals performing a non-sterile diagnostic procedure for colonoscopies to help protect the patient and staff from bodily secretions and to maintain a cleaner procedural site. The device is a single use disposable drape that is provided non-sterile. The device can, however, be EtO (ethelene oxide) sterilized by the end user prior to use.

Source page: https://510kreport.com/device/K070406
Methodology: https://510kreport.com/methodology