Cleared Traditional

K965005 - IAMIN IMPREGNATED GAUZE DRESSING

K965005 · Procyte Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
70d
Days
-
Risk

K965005 is an FDA 510(k) clearance for the IAMIN IMPREGNATED GAUZE 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 24, 1997 after a review of 70 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 Procyte Corp. devices

FDA 510(k) Submission Details - K965005

510(k) Number K965005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1996
Decision Date February 24, 1997
Days to Decision 70 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
45d faster than avg
Panel avg: 115d · This submission: 70d
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 46
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K965005.
AMERIGEL OINTMENT
K970133 · Amerx Health Care Corp. · Apr 1997
B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING
K970453 · B.Braun Medical, Inc. · Apr 1997
ACRYDERM GEL WOUND DRESSING
K970693 · Acrymed, Inc. · Mar 1997
IAMIN WET DRESSING (COPPER-SALINE)
K964468 · Procyte Corp. · Feb 1997
PANOGAUZE NON-WOVEN HYDROGEL DRESSING
K964620 · Sage Pharmaceuticals, Inc. · Jan 1997
BRENNEN MEDICAL GLUCAN II WOUND DRESSING
K964241 · Brennen Medical, Inc. · Dec 1996