Cleared Traditional

CALSSIQUE OR MYSTIQUE (K932978) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K932978 · Dekumed, Kunststofftechnik Degler GmbH · General & Plastic Surgery device
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Dec 1993
Decision
188d
Days
Class 1
Risk

K932978 is an FDA 510(k) clearance for the CALSSIQUE OR MYSTIQUE. Classified as Prosthesis, Breast, External, Used With Adhesive (product code KCZ), Class I - General Controls.

Submitted by Dekumed, Kunststofftechnik Degler GmbH (Germany, DE). The FDA issued a Cleared decision on December 22, 1993 after a review of 188 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3800 - 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 Dekumed, Kunststofftechnik Degler GmbH devices

Submission Details

510(k) Number K932978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1993
Decision Date December 22, 1993
Days to Decision 188 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
73d slower than avg
Panel avg: 115d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KCZ Prosthesis, Breast, External, Used With Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.3800
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.