Cleared Traditional

K953853 - IAMIN GEL WOUND DRESSING

K953853 · Procyte Corp. · General & Plastic Surgery device
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Feb 1996
Decision
173d
Days
-
Risk

K953853 is an FDA 510(k) clearance for the IAMIN GEL WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Procyte Corp. (Kirkland, US). The FDA issued a Cleared decision on February 5, 1996 after a review of 173 days - an extended review 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: 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 Procyte Corp. devices

FDA 510(k) Submission Details - K953853

510(k) Number K953853 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 16, 1995
Decision Date February 05, 1996
Days to Decision 173 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
58d slower than avg
Panel avg: 115d · This submission: 173d
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 47
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K953853.
PANOGAUZE NON-WOVEN HYDROGEL DRESSING
K964620 · Sage Pharmaceuticals, Inc. · Jan 1997
BRENNEN MEDICAL GLUCAN II WOUND DRESSING
K964241 · Brennen Medical, Inc. · Dec 1996
DERMAPLEX HYDROGEL WOUND DRESSING
K962513 · Maxxim Medical · Sep 1996
TECNOL HYDROGEL WOUND DRESSING
K955575 · Tecnol Medical Products, Inc. · Jan 1996
AQUAFLO BTP HYDROGEL WOUND DRESSING
K952938 · Sherwood Medical Co. · Dec 1995
DERMAGRAN (ZINC SALINE) HYDROGEL WOUND DRESSING
K954664 · Derma Sciences, Inc. · Nov 1995