Cleared Traditional

K914746 - DERMAGRAN WET DRESSING (FDA 510(k) Clearance)

K914746 · Derma Sciences, Inc. · General & Plastic Surgery device
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Jun 1992
Decision
239d
Days
-
Risk

K914746 is an FDA 510(k) clearance for the DERMAGRAN WET DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Derma Sciences, Inc. (Old Forge, US). The FDA issued a Cleared decision on June 17, 1992 after a review of 239 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 Derma Sciences, Inc. devices

Submission Details

510(k) Number K914746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1991
Decision Date June 17, 1992
Days to Decision 239 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 114d · This submission: 239d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -