Cleared Traditional

K864185 - MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN

K864185 · Mcghan Medical Corp. · General & Plastic Surgery device
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Dec 1986
Decision
58d
Days
-
Risk

K864185 is an FDA 510(k) clearance for the MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN. 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, 1986 after a review of 58 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

FDA 510(k) Submission Details - K864185

510(k) Number K864185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1986
Decision Date December 24, 1986
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

LCJ Device Classification - Class 0,

Product Code LCJ Tissue Expander And Accessories
Device Class -

Regulatory Peers - LCJ Tissue Expander And Accessories

All 40
Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K864185.
SURGITEK(R) EXTERNAL FILL PORT
K894495 · Surgitek · Jan 1990
SURGITEK FLAT T-SPAN
K884746 · Medical Engineering Corp. · Aug 1989
RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)
K884250 · Mentor Corp. · Jun 1989
MENTOR FLAT-SPAN
K862049 · Mentor Corp. · Jun 1986
TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600
K845036 · Progress Mankind Technology · Jun 1985
MENTOR EXPANDER MAMMARY PROSTHESIS
K844813 · Mentor Corp. · May 1985