Cleared Traditional

K965143 - OSMOCYTE WOUND MANAGER SHEET DRESSING

K965143 · Procyte Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 1997
Decision
150d
Days
-
Risk

K965143 is an FDA 510(k) clearance for the OSMOCYTE WOUND MANAGER SHEET 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 May 22, 1997 after a review of 150 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 - K965143

510(k) Number K965143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1996
Decision Date May 22, 1997
Days to Decision 150 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
35d slower than avg
Panel avg: 115d · This submission: 150d
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 K965143.
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K970133 · Amerx Health Care Corp. · Apr 1997
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K970453 · B.Braun Medical, Inc. · Apr 1997
ACRYDERM GEL WOUND DRESSING
K970693 · Acrymed, Inc. · Mar 1997