Cleared Traditional

ROYL-DERM WOUND HYDROGEL (K922815) - FDA 510(k) Clearance

K922815 · Renaissance Medical, Inc. · General & Plastic Surgery device
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Oct 1992
Decision
139d
Days
-
Risk

K922815 is an FDA 510(k) clearance for the ROYL-DERM WOUND HYDROGEL. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Renaissance Medical, Inc. (Dana Point, US). The FDA issued a Cleared decision on October 28, 1992 after a review of 139 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K922815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1992
Decision Date October 28, 1992
Days to Decision 139 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
24d slower than avg
Panel avg: 115d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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