Cleared Traditional

ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT (K905484) - FDA 510(k) Clearance

K905484 · Mentor Corp. · General & Plastic Surgery device
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Feb 1991
Decision
67d
Days
-
Risk

K905484 is an FDA 510(k) clearance for the ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Mentor Corp. (Goleta, US). The FDA issued a Cleared decision on February 11, 1991 after a review of 67 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K905484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1990
Decision Date February 11, 1991
Days to Decision 67 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
48d faster than avg
Panel avg: 115d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCJ Tissue Expander And Accessories
Device Class -