Cleared Traditional

K933465 - COSMET

K933465 is an FDA 510(k) clearance for COSMET, manufactured by Great Bay Medical Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KCZ cleared through the Traditional 510(k) pathway after a 369-day FDA review.

K933465 · Great Bay Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K933465

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.

KCZ Device Classification - Class 1, General Controls

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.

Regulatory Peers - KCZ Prosthesis, Breast, External, Used With Adhesive

Devices cleared under the same product code (KCZ) and FDA review panel - the closest regulatory comparables to K933465.
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K904086 · Coloplast A/S · Oct 1990