Cleared Traditional

K953816 - DCURASOL GEL WOUND DRESSING

K953816 · Dpt Laboratories, Ltd. · General & Plastic Surgery device
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Aug 1995
Decision
13d
Days
-
Risk

K953816 is an FDA 510(k) clearance for the DCURASOL GEL WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Dpt Laboratories, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on August 28, 1995 after a review of 13 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.

FDA 510(k) Submission Details - K953816

510(k) Number K953816 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 15, 1995
Decision Date August 28, 1995
Days to Decision 13 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
102d faster than avg
Panel avg: 115d · This submission: 13d
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 138
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K953816.
WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL
K954384 · Renaissance Pharmaceutical, Inc. · Oct 1995
DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING
K952775 · Deroyal Industries, Inc. · Oct 1995
PERSPECTIVES IMPREGNATED HYDROGEL WOUND DRESSING
K953669 · Marketing Perspectives · Sep 1995
CURASOL GEL WOUND DRESSING
K953450 · Dpt Laboratories, Ltd. · Aug 1995
BURNSHIELD TRAUMA DRESSING
K952247 · Golightly International Corp. · Jul 1995
STERIGAUZE GEL DRESSING
K952419 · Acacia Laboratories, Inc. · Jul 1995
K953816 · DCURASOL GEL WOUND DRESSING
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