Cleared Traditional

K041704 - NEWGEL AND NEWGEL PLUS E (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K041704 · Newmedical Technology, Inc. · General & Plastic Surgery device
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Oct 2005
Decision
481d
Days
Class 1
Risk

K041704 is an FDA 510(k) clearance for the NEWGEL AND NEWGEL PLUS E. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Newmedical Technology, Inc. (Northbrook, US). The FDA issued a Cleared decision on October 17, 2005 after a review of 481 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4025 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Newmedical Technology, Inc. devices

Submission Details

510(k) Number K041704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2004
Decision Date October 17, 2005
Days to Decision 481 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
367d slower than avg
Panel avg: 114d · This submission: 481d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MDA Elastomer, Silicone, For Scar Management
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4025
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.