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.

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 138

Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K964620.

BIONECT CREAM

K963004 · Fidia Pharmaceutical Corp. · Feb 1997

IAMIN WET DRESSING (COPPER-SALINE)

K964468 · Procyte Corp. · Feb 1997

BIAFINE WOUND DRESSING EMULSION

K964240 · Medix Pharmaceuticals Americas, Inc. · Jan 1997

MULTIDEX HYDROPHILIC WOUND DRESSING GEL

K962917 · Lange Medical Products, Inc. · Dec 1996

BRENNEN MEDICAL GLUCAN II WOUND DRESSING

K964241 · Brennen Medical, Inc. · Dec 1996

DERMAMEND GEL

K962089 · Dermarx Corp. · Nov 1996

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K964620

Sage Pharmaceuticals, Inc.

Shreveport, LA · US

WILLIAM J ROCHE

Regulatory profile

2 submissions 1 cleared

50% clearance rate · Active in General & Plastic Surgery

View all devices by Sage Pharmaceuticals, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: January 9, 1997. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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