Cleared Traditional

K933817 - ROYL-DERM WOUND HYDROGEL STERILE UNIT DOSE

K933817 · Renaissance Medical, Inc. · General & Plastic Surgery device
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Jan 1994
Decision
159d
Days
-
Risk

K933817 is an FDA 510(k) clearance for the ROYL-DERM WOUND HYDROGEL STERILE UNIT DOSE. 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 159 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

FDA 510(k) Submission Details - K933817

510(k) Number K933817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1993
Decision Date January 10, 1994
Days to Decision 159 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
44d slower than avg
Panel avg: 115d · This submission: 159d
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 93
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K933817.
A GEL WOUND DRESSING
K951862 · Polymedica Industries, Inc. · Jul 1995
CURAFIL WOUND GEL DRESSING
K943073 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jul 1994
BIOLEX IMPREGNATED WOUND DRESSING
K935096 · C.R. Bard, Inc. · Feb 1994
DUODERM IMPROVED CGF CONTROL GEL FORMULA DRESSING
K932101 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993
SOLOSITE DERMAL WOUND GEL
K932263 · Smith & Nephew United, Inc. · Oct 1993
DERMAGRAN WET DRESSING (ZINC-SALINE)
K913344 · Derma Sciences, Inc. · Jul 1992