Cleared Traditional

K954741 - DERMAGRAN WENT DRESSING (DEXTROSE-SALINE) (FDA 510(k) Clearance)

K954741 · Derma Sciences, Inc. · General & Plastic Surgery device
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Nov 1995
Decision
16d
Days
-
Risk

K954741 is an FDA 510(k) clearance for the DERMAGRAN WENT DRESSING (DEXTROSE-SALINE). 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 November 1, 1995 after a review of 16 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 Derma Sciences, Inc. devices

Submission Details

510(k) Number K954741 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 16, 1995
Decision Date November 01, 1995
Days to Decision 16 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 114d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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