Cleared Traditional

K964468 - IAMIN WET DRESSING (COPPER-SALINE)

K964468 · Procyte Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
89d
Days
-
Risk

K964468 is an FDA 510(k) clearance for the IAMIN WET DRESSING (COPPER-SALINE). 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 3, 1997 after a review of 89 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.

FDA 510(k) Submission Details - K964468

510(k) Number K964468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1996
Decision Date February 03, 1997
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 115d · This submission: 89d
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 138
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K964468.
ACRYDERM GEL WOUND DRESSING
K970693 · Acrymed, Inc. · Mar 1997
IAMIN IMPREGNATED GAUZE DRESSING
K965005 · Procyte Corp. · Feb 1997
BIONECT CREAM
K963004 · Fidia Pharmaceutical Corp. · Feb 1997
BIAFINE WOUND DRESSING EMULSION
K964240 · Medix Pharmaceuticals Americas, Inc. · Jan 1997
PANOGAUZE NON-WOVEN HYDROGEL DRESSING
K964620 · Sage Pharmaceuticals, Inc. · Jan 1997
MULTIDEX HYDROPHILIC WOUND DRESSING GEL
K962917 · Lange Medical Products, Inc. · Dec 1996
K964468 · IAMIN WET DRESSING (COPPER-SALINE)
Download PDF FDA Summary Procyte Corp.