Cleared Traditional

K111313 - EXSEPT SKIN AND WOUND CLEANSER WITH ANT...

K111313 is an FDA 510(k) clearance for EXSEPT SKIN AND WOUND CLEANSER WITH ANT..., manufactured by Alcavis Hdc, LLC. The device is a Class 2 General Hospital device with product code FQH cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K111313 · Alcavis Hdc, LLC · General Hospital
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Dec 2011
Decision
218d
Days
Class 2
Risk

K111313 is an FDA 510(k) clearance for the EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Alcavis Hdc, LLC (Gaithersburg, US). The FDA issued a Cleared decision on December 14, 2011 after a review of 218 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 Hdc, LLC devices

FDA 510(k) Submission Details - K111313

510(k) Number K111313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2011
Decision Date December 14, 2011
Days to Decision 218 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 129d · This submission: 218d
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 34
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K111313.
SURGIPHOR Wound Irrigation System
K202071 · Orthophor, LLC · Oct 2020
Bactisure Wound Lavage
K192349 · Next Science, LLC · Jan 2020
The VersaJet II Hydrosurgery System
K143115 · Smith & Nephew, Inc. · Jul 2015
VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH
K110958 · Smith & Nephew, Inc. · Aug 2011
ERBE ERBEJET 2 SYSTEM
K072404 · Erbe USA, Inc. · Oct 2007
ERBE HELIX HYDRO-JET
K033590 · Erbe USA, Inc. · Jan 2004