Cleared Traditional

K924008 - STERILE FILM WOUND DRESSING

K924008 · Innovative Technology , Ltd. · General & Plastic Surgery device
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Nov 1992
Decision
106d
Days
-
Risk

K924008 is an FDA 510(k) clearance for the STERILE FILM WOUND DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Innovative Technology , Ltd. (Ontario L3y 1j8, CA). The FDA issued a Cleared decision on November 24, 1992 after a review of 106 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Innovative Technology , Ltd. devices

FDA 510(k) Submission Details - K924008

510(k) Number K924008 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 10, 1992
Decision Date November 24, 1992
Days to Decision 106 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 115d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 58
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K924008.
CUTIFILM(R) FILM
K926399 · Beiersdorf, Inc. · Nov 1993
HYDRASORB STERILE DRESSING
K931599 · Calgon Vestal Div. · Jul 1993
EPI-LOCK WOUND DRESSING
K926034 · Calgon Vestal Div. · Apr 1993
DEROYAL TRANSPARENT FILM DRESSIGN
K920796 · Deroyal Industries, Inc. · Jul 1992
PROCEL BURN COVER
K915695 · W.L. Gore & Associates, Inc. · May 1992
CURITY VENTED DRESSING SYSTEM
K915635 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jan 1992