Cleared Traditional

K903448 - SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER

K903448 · Medical Engineering Corp. · General & Plastic Surgery device
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Jan 1991
Decision
167d
Days
-
Risk

K903448 is an FDA 510(k) clearance for the SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Medical Engineering Corp. (Paso Robles, US). The FDA issued a Cleared decision on January 14, 1991 after a review of 167 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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.

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Submission Details

510(k) Number K903448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1990
Decision Date January 14, 1991
Days to Decision 167 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
52d slower than avg
Panel avg: 115d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCJ Tissue Expander And Accessories
Device Class -