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Endodrape

FDA 510(k)

Class II (US FDA 510(k))

510(k) K070406

by Vortek Surgical, LLC

Identifiers

510(k) Number
K070406 FDA 510(k)
FDA Product Code
KKX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4370 FDA 510(k)
Regulation Number
878.4370 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Endodrape is a surgical and diagnostic procedure drape used to protect patients and staff from bodily secretions and maintain a cleaner procedural site during non-sterile diagnostic procedures such as colonoscopies and upper endoscopy. It is a single-use disposable drape.

The Endodrape is supplied as a single-use device and is intended for use in medical procedures. It has received FDA 510(k) clearance, with the specific clearance number being K070406. The device is manufactured by Vortek Surgical, LLC.

Frequently asked questions

What is the Endodrape used for?

The Endodrape is used to protect patients and staff from bodily secretions and maintain a cleaner procedural site during non-sterile diagnostic procedures.

Is the Endodrape sterile?

The Endodrape is intended for use in non-sterile diagnostic procedures, but it is supplied as a single-use disposable device.

Can the Endodrape be reused?

No, the Endodrape is a single-use device and should not be reused.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ENDODRAPE (K070406) — FDA 510 (k) | Innolitics, ENDODRAPE(TM) (K080341) — FDA 510(k) | Innolitics, ENDODRAPE(TM) (K080341) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vortek Surgical, LLC

Sources (1)

  • FDA 510(k) K070406 24 fields · synced Oct 6, 2026