Cleared Abbreviated

K080341 - ENDODRAPE(TM)

K080341 is an FDA 510(k) clearance for ENDODRAPE(TM), manufactured by Vortek Surgical, LLC. The device is a Class 2 General Hospital device with product code KKX cleared through the Abbreviated 510(k) pathway after a 164-day FDA review.

K080341 · Vortek Surgical, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
164d
Days
Class 2
Risk

K080341 is an FDA 510(k) clearance for the ENDODRAPE(TM). Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Vortek Surgical, LLC (Indianapolis, US). The FDA issued a Cleared decision on July 21, 2008 after a review of 164 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K080341

510(k) Number K080341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2008
Decision Date July 21, 2008
Days to Decision 164 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 129d · This submission: 164d
Pathway characteristics
Standards-based clearance path.

KKX Device Classification - Class 2, Special Controls

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KKX Drape, Surgical

All 420
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K080341.
SRI LP DRAPE
K080796 · Sri/Surgical Express · Nov 2008
PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS
K080629 · Promedical Products Co., Ltd. · Oct 2008
SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE
K081476 · Surgical Concept Designs · Aug 2008
ARROW INTERNATIONAL, INC., SURGICAL DRAPES
K071491 · Arrow Intl., Inc. · Oct 2007
GENERAL SURGERY DRAPES
K070432 · Welmed, Inc. · Sep 2007
ENDODRAPE
K070406 · Vortek Surgical, LLC · Jul 2007
K080341 · ENDODRAPE(TM)
Download PDF FDA Summary Vortek Surgical, LLC