Cleared Traditional

MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL (K883619) - FDA 510(k) Clearance

K883619 · Minnetonka, Inc. · General & Plastic Surgery device
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Sep 1989
Decision
373d
Days
-
Risk

K883619 is an FDA 510(k) clearance for the MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL. Classified as Wound Dressings With Hydrocortisone (product code SEK).

Submitted by Minnetonka, Inc. (Minnetonka, US). The FDA issued a Cleared decision on September 1, 1989 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K883619 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 24, 1988
Decision Date September 01, 1989
Days to Decision 373 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
258d slower than avg
Panel avg: 115d · This submission: 373d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SEK Wound Dressings With Hydrocortisone
Device Class -
Definition A Wound Dressing Containing Hydrocortisone Is Used To Maintain Appropriate Moisture Balance Within The Wound