Cleared Traditional

MCGHAN INTEGRAL VALVE TISSUE EXPANDER (K854794) - FDA 510(k) Clearance

K854794 · Mcghan Medical Corp. · General & Plastic Surgery device
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Dec 1985
Decision
22d
Days
-
Risk

K854794 is an FDA 510(k) clearance for the MCGHAN INTEGRAL VALVE TISSUE EXPANDER. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Mcghan Medical Corp. (Santa Barbara, US). The FDA issued a Cleared decision on December 24, 1985 after a review of 22 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.

View all Mcghan Medical Corp. devices

Submission Details

510(k) Number K854794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1985
Decision Date December 24, 1985
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
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCJ Tissue Expander And Accessories
Device Class -