Cleared Traditional

SILGEL STC-S (K984029) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K984029 · Nagor , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
266d
Days
Class 1
Risk

K984029 is an FDA 510(k) clearance for the SILGEL STC-S. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Nagor , Ltd. (British Isles, VG). The FDA issued a Cleared decision on August 5, 1999 after a review of 266 days - an extended review cycle.

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: 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 Nagor , Ltd. devices

Submission Details

510(k) Number K984029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1998
Decision Date August 05, 1999
Days to Decision 266 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
151d slower than avg
Panel avg: 115d · This submission: 266d
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.