Cleared Traditional

K853014 - MCGHAN TISSUE EXPANDER FILL KIT

K853014 · Mcghan Medical Corp. · General & Plastic Surgery device
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Sep 1985
Decision
63d
Days
-
Risk

K853014 is an FDA 510(k) clearance for the MCGHAN TISSUE EXPANDER FILL KIT. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Mcghan Medical Corp. (Santa Barbara, US). The FDA issued a Cleared decision on September 18, 1985 after a review of 63 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 K853014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1985
Decision Date September 18, 1985
Days to Decision 63 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 faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCJ Tissue Expander And Accessories
Device Class -

Regulatory Peers - LCJ Tissue Expander And Accessories

All 20
Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K853014.
MENTOR TISSUE EXPANDERS W/TDMAC COATING
K894475 · Mentor Corp. · Nov 1990
RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)
K884250 · Mentor Corp. · Jun 1989
MENTOR FLAT-SPAN
K862049 · Mentor Corp. · Jun 1986
MENTOR EXPANDER MAMMARY PROSTHESIS
K844813 · Mentor Corp. · May 1985
RADOVAN TISSUE EXPANDER
K842883 · Mentor Corp. · Aug 1984