Cleared Traditional

K973657 - ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING

K973657 · Maersk Medical, Ltd. · General & Plastic Surgery device
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Dec 1997
Decision
67d
Days
-
Risk

K973657 is an FDA 510(k) clearance for the ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Maersk Medical, Ltd. (St Louis, US). The FDA issued a Cleared decision on December 1, 1997 after a review of 67 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Maersk Medical, Ltd. devices

FDA 510(k) Submission Details - K973657

510(k) Number K973657 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 25, 1997
Decision Date December 01, 1997
Days to Decision 67 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
48d faster than avg
Panel avg: 115d · This submission: 67d
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 K973657.
SIMPLICARE THIN FILM WOUND DRESSINGS
K980209 · Hollister, Inc. · Feb 1998
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
3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES
K973036 · 3M Healthcare · Nov 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