Cleared Traditional

INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER (K904265) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K904265 · Inamed Development Co. · General & Plastic Surgery device
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Mar 1991
Decision
169d
Days
Class 1
Risk

K904265 is an FDA 510(k) clearance for the INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER. Classified as Expander, Surgical, Skin Graft (product code FZW), Class I - General Controls.

Submitted by Inamed Development Co. (Carpinteria, US). The FDA issued a Cleared decision on March 6, 1991 after a review of 169 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Inamed Development Co. devices

Submission Details

510(k) Number K904265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1990
Decision Date March 06, 1991
Days to Decision 169 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 115d · This submission: 169d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FZW Expander, Surgical, Skin Graft
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.