Cleared Traditional

K883303 - MENTOR RAPID-SPAN (TM) TISSUE EXPANDER (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K883303 · Mentor Corp. · General & Plastic Surgery device
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Aug 1988
Decision
22d
Days
Class 1
Risk

K883303 is an FDA 510(k) clearance for the MENTOR RAPID-SPAN (TM) TISSUE EXPANDER. Classified as Expander, Surgical, Skin Graft (product code FZW), Class I - General Controls.

Submitted by Mentor Corp. (Goleta, US). The FDA issued a Cleared decision on August 26, 1988 after a review of 22 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mentor Corp. devices

Submission Details

510(k) Number K883303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1988
Decision Date August 26, 1988
Days to Decision 22 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
92d faster than avg
Panel avg: 114d · This submission: 22d
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.