Cleared Traditional

COSMET (K933465) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K933465 · Great Bay Medical Products, Inc. · General & Plastic Surgery device
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Jul 1994
Decision
369d
Days
Class 1
Risk

K933465 is an FDA 510(k) clearance for the COSMET. Classified as Prosthesis, Breast, External, Used With Adhesive (product code KCZ), Class I - General Controls.

Submitted by Great Bay Medical Products, Inc. (Dover, US). The FDA issued a Cleared decision on July 20, 1994 after a review of 369 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 878.3800 - 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. Elevated predicate reliance profile. 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 Great Bay Medical Products, Inc. devices

Submission Details

510(k) Number K933465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1993
Decision Date July 20, 1994
Days to Decision 369 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
254d slower than avg
Panel avg: 115d · This submission: 369d
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.