Cleared Traditional

K962513 - DERMAPLEX HYDROGEL WOUND DRESSING

K962513 · Maxxim Medical · General & Plastic Surgery device
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Sep 1996
Decision
77d
Days
-
Risk

K962513 is an FDA 510(k) clearance for the DERMAPLEX HYDROGEL WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Maxxim Medical (Fort Worth, US). The FDA issued a Cleared decision on September 12, 1996 after a review of 77 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 Maxxim Medical devices

FDA 510(k) Submission Details - K962513

510(k) Number K962513 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 27, 1996
Decision Date September 12, 1996
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 94
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K962513.
DERMAMEND GEL
K962089 · Dermarx Corp. · Nov 1996
CHONDROPROTEC
K961930 · The Hymed Group Corp. · Oct 1996
CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG
K962218 · Carrington Laboratories, Inc. · Sep 1996
ACRYNOODLES ABSORBENT WOUND DRESSING
K962851 · Acrymed, Inc. · Sep 1996
DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)
K962439 · Richard Hamer Assoc., Inc. · Sep 1996
HYCOAT
K960686 · The Hymed Group Corp. · Aug 1996