Cleared Traditional

K973036 - 3M TEGADERM TRANSPARENT DRESSING

K973036 · 3M Healthcare · General & Plastic Surgery device
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Nov 1997
Decision
90d
Days
-
Risk

K973036 is an FDA 510(k) clearance for the 3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID.... Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by 3M Healthcare (St. Paul, US). The FDA issued a Cleared decision on November 12, 1997 after a review of 90 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.

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FDA 510(k) Submission Details - K973036

510(k) Number K973036 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 14, 1997
Decision Date November 12, 1997
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 15
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K973036.
SIMPLICARE TRANSPARENT WOUND DRESSING
K991214 · Hollister, Inc. · Oct 1999
CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0
K981713 · Smith & Nephew, Inc. · Jul 1998
SIMPLICARE THIN FILM WOUND DRESSINGS
K980209 · Hollister, Inc. · Feb 1998
EPIVIEW
K961319 · Convatec, A Division of E.R. Squibb & Sons · Jul 1996
DERMAGRAN HYDROPHILIC WOUND DRESSING
K954738 · Derma Sciences, Inc. · Nov 1995
ULTEC THIN HYDROCOLLOID DRESSING
K952071 · Sherwood Medical Co. · Jun 1995