Cleared Special

K112341 - SNAP WOUND CARE SYSTEM

K112341 is an FDA 510(k) clearance for SNAP WOUND CARE SYSTEM, manufactured by Spiracur, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OKO cleared through the Special 510(k) pathway after a 14-day FDA review.

K112341 · Spiracur, Inc. · General & Plastic Surgery device
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Aug 2011
Decision
14d
Days
Class 2
Risk

K112341 is an FDA 510(k) clearance for the SNAP WOUND CARE SYSTEM. Classified as Negative Pressure Wound Therapy Non-powered Suction Apparatus (product code OKO), Class II - Special Controls.

Submitted by Spiracur, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 29, 2011 after a review of 14 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4683 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spiracur, Inc. devices

FDA 510(k) Submission Details - K112341

510(k) Number K112341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2011
Decision Date August 29, 2011
Days to Decision 14 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

OKO Device Classification - Class 2, Special Controls

Product Code OKO Negative Pressure Wound Therapy Non-powered Suction Apparatus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4683
Definition A Non-powered Suction Apparatus Indicated For Negative Pressure Wound Therapy (npwt) That Is Intended For Wound Management Via Application Of Continual Or Intermittent Negative Pressure To The Wound For Removal Of Fluids, Including Wound Exudate, Irrigation Fluids, And Infectious Materials.
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OKO Negative Pressure Wound Therapy Non-powered Suction Apparatus

All 16
Devices cleared under the same product code (OKO) and FDA review panel - the closest regulatory comparables to K112341.
SNAP WOUND CARE SYSTEM
K132080 · Spiracur, Inc. · Mar 2014
CISNAP CLOSED INCISION SYSTEM
K133137 · Spiracur, Inc. · Feb 2014
SNAP WOUND CARE SYSTEM
K113032 · Spiracur, Inc. · Dec 2011
SNAP (R) WOUND CARE SYSTEM
K111393 · Spiracur, Inc. · Jul 2011
CI-SNAP WOUND CARE SYSTEM
K111006 · Spiracur, Inc. · Jul 2011
SNAP WOUND CARE DEVICE
DEN080011 · Spiracur, Inc. · Aug 2009