Cleared Traditional

K864184 - MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SA...

K864184 · Mcghan Medical Corp. · General & Plastic Surgery device

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Dec 1986

Decision

58d

Days

Risk

K864184 is an FDA 510(k) clearance for the MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE 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

Submission Details

510(k) Number	K864184 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.

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 K864184.

ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT

K905484 · Mentor Corp. · Feb 1991

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

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K864184

Mcghan Medical Corp.

Santa Barbara, CA · US

LAURENS LICHTY

Regulatory profile

14 submissions 14 cleared

100% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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