Cleared Traditional

K943073 - CURAFIL WOUND GEL DRESSING

K943073 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery device
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Jul 1994
Decision
28d
Days
-
Risk

K943073 is an FDA 510(k) clearance for the CURAFIL WOUND GEL DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on July 26, 1994 after a review of 28 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K943073

510(k) Number K943073 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 28, 1994
Decision Date July 26, 1994
Days to Decision 28 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
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 24
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K943073.
DERMAGRAN (ZINC SALINE) HYDROGEL WOUND DRESSING
K954664 · Derma Sciences, Inc. · Nov 1995
DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)
K954741 · Derma Sciences, Inc. · Nov 1995
DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING
K952775 · Deroyal Industries, Inc. · Oct 1995
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