Not Cleared Post-NSE

DEN080011 - SNAP WOUND CARE DEVICE (FDA 510(k) Clearance)

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

DEN080011 · Spiracur, Inc. · General & Plastic Surgery device
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Aug 2009
Decision
277d
Days
Class 2
Risk

DEN080011 is an FDA 510(k) submission (not cleared) for the SNAP WOUND CARE DEVICE. Classified as Negative Pressure Wound Therapy Non-powered Suction Apparatus (product code OKO), Class II - Special Controls.

Submitted by Spiracur, Inc. (Philadelphia, US). The FDA issued a Not Cleared (DENG) decision on August 7, 2009 after a review of 277 days.

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. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 277 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Spiracur, Inc. devices

Submission Details

510(k) Number DEN080011 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 03, 2008
Decision Date August 07, 2009
Days to Decision 277 days
Submission Type Post-NSE
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 114d · This submission: 277d
Pathway characteristics

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.