Cleared Traditional

K964620 - PANOGAUZE NON-WOVEN HYDROGEL DRESSING

K964620 · Sage Pharmaceuticals, Inc. · General & Plastic Surgery device
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Jan 1997
Decision
52d
Days
-
Risk

K964620 is an FDA 510(k) clearance for the PANOGAUZE NON-WOVEN HYDROGEL DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Sage Pharmaceuticals, Inc. (Shreveport, US). The FDA issued a Cleared decision on January 9, 1997 after a review of 52 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 Sage Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K964620

510(k) Number K964620 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 18, 1996
Decision Date January 09, 1997
Days to Decision 52 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
63d faster than avg
Panel avg: 115d · This submission: 52d
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 K964620.
ACRYDERM GEL WOUND DRESSING
K970693 · Acrymed, Inc. · Mar 1997
IAMIN IMPREGNATED GAUZE DRESSING
K965005 · Procyte Corp. · Feb 1997
IAMIN WET DRESSING (COPPER-SALINE)
K964468 · Procyte Corp. · Feb 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