Cleared Special

K111393 - SNAP (R) WOUND CARE SYSTEM (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K111393 · Spiracur, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
71d
Days
Class 2
Risk

K111393 is an FDA 510(k) clearance for the SNAP (R) 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 July 28, 2011 after a review of 71 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

Submission Details

510(k) Number K111393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2011
Decision Date July 28, 2011
Days to Decision 71 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
43d faster than avg
Panel avg: 114d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.