Cleared Traditional

K921810 - CURASOL(TM) WOUND DRESSING

K921810 · Healthsouth Medical Center · General & Plastic Surgery device
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Jul 1992
Decision
99d
Days
-
Risk

K921810 is an FDA 510(k) clearance for the CURASOL(TM) WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Healthsouth Medical Center (Fort Worth, US). The FDA issued a Cleared decision on July 23, 1992 after a review of 99 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.

View all Healthsouth Medical Center devices

FDA 510(k) Submission Details - K921810

510(k) Number K921810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1992
Decision Date July 23, 1992
Days to Decision 99 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
16d faster than avg
Panel avg: 115d · This submission: 99d
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 23
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K921810.
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
DERMAGRAN WET DRESSING
K914746 · Derma Sciences, Inc. · Jun 1992
DUODERM HYDROACTIVE DRESSING AND CGF DRESSINGS
K912667 · Convatec, A Division of E.R. Squibb & Sons · Sep 1991