Cleared Traditional

K973036 - 3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES

K973036 · 3M Healthcare · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all 3M Healthcare devices

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
Combination Product No
PCCP Authorized No
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 60
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K973036.
SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM
K974520 · Innovative Technologies (Us), Inc. · Feb 1998
N-TERFACE
K973538 · Winfield Laboratories, Inc. · Dec 1997
ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING
K973657 · Maersk Medical, Ltd. · Dec 1997
SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED
K964398 · Polymedica Industries, Inc. · Oct 1997
TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING
K973312 · Innovative Technologies , Ltd. · Oct 1997
HYDRASORB STERILE DRESSING
K973260 · Avitar, Inc. · Oct 1997