Cleared Traditional

K833083 - DERMA STRIP-TM SKIN CLOSURES (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K833083 · Howmedica Corp. · General & Plastic Surgery device
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Dec 1983
Decision
109d
Days
Class 1
Risk

K833083 is an FDA 510(k) clearance for the DERMA STRIP-TM SKIN CLOSURES. Classified as Strip, Adhesive, Closure, Skin (product code FPX), Class I - General Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on December 30, 1983 after a review of 109 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - the FDA general and plastic surgery device framework. 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 Howmedica Corp. devices

Submission Details

510(k) Number K833083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1983
Decision Date December 30, 1983
Days to Decision 109 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
5d faster than avg
Panel avg: 114d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FPX Strip, Adhesive, Closure, Skin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.