Cleared Traditional

IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II (K941960) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K941960 · Implantech Associates, Inc. · General & Plastic Surgery device
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Aug 1994
Decision
117d
Days
Class 2
Risk

K941960 is an FDA 510(k) clearance for the IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II. Classified as Prosthesis, Nose, Internal (product code FZE), Class II - Special Controls.

Submitted by Implantech Associates, Inc. (Washington, US). The FDA issued a Cleared decision on August 17, 1994 after a review of 117 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3680 - 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 Implantech Associates, Inc. devices

Submission Details

510(k) Number K941960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1994
Decision Date August 17, 1994
Days to Decision 117 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 115d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FZE Prosthesis, Nose, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.