Cleared Traditional

K082858 - EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER

K082858 is an FDA 510(k) clearance for EXSEPT WC ANTIMICROBIAL SKIN AND WOUND ..., manufactured by Alcavis International, Inc.. The device is a Class 2 General Hospital device with product code FQH cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K082858 · Alcavis International, Inc. · General Hospital
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May 2009
Decision
240d
Days
Class 2
Risk

K082858 is an FDA 510(k) clearance for the EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Alcavis International, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on May 27, 2009 after a review of 240 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5475 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Alcavis International, Inc. devices

FDA 510(k) Submission Details - K082858

510(k) Number K082858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2008
Decision Date May 27, 2009
Days to Decision 240 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 129d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FQH Device Classification - Class 2, Special Controls

Product Code FQH Lavage, Jet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5475
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 - FQH Lavage, Jet

All 43
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K082858.
EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE
K111313 · Alcavis Hdc, LLC · Dec 2011
VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH
K110958 · Smith & Nephew, Inc. · Aug 2011
PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM
K090848 · Premier Brands of America, Inc. · Jun 2009
IRRISEPT WOUND CLEANSING SYSTEM
K080779 · Irrimax Corporation · Feb 2009
ERBE ERBEJET 2 SYSTEM
K072404 · Erbe USA, Inc. · Oct 2007
VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE
K060782 · Smith & Nephew Wound Management · Apr 2006