Cleared Traditional

ROYL-DERM WOUND HYDROGEL DRESSING (K932973) - FDA 510(k) Clearance

K932973 · Renaissance Medical, Inc. · General & Plastic Surgery device
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Jan 1994
Decision
210d
Days
-
Risk

K932973 is an FDA 510(k) clearance for the ROYL-DERM WOUND HYDROGEL DRESSING. 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 January 10, 1994 after a review of 210 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 Renaissance Medical, Inc. devices

Submission Details

510(k) Number K932973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1993
Decision Date January 10, 1994
Days to Decision 210 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
95d slower than avg
Panel avg: 115d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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