Cleared Traditional

K862203 - MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER

K862203 · Mcghan Medical Corp. · General & Plastic Surgery device

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Jul 1986

Decision

43d

Days

Risk

K862203 is an FDA 510(k) clearance for the MCGHAN MAGNA-SITE(TM) 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 July 23, 1986 after a review of 43 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 - K862203

510(k) Number	K862203 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 10, 1986
Decision Date	July 23, 1986
Days to Decision	43 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

72d faster than avg

Panel avg: 115d · This submission: 43d

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 K862203.

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

FDA 510(k) Resources - General & Plastic Surgery

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

Manufacturer of K862203

Mcghan Medical Corp.

Santa Barbara, CA · US

LAURENS LICHTY

Regulatory profile

14 submissions 14 cleared

100% clearance rate · Active in General & Plastic Surgery

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

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 . FDA decision: July 23, 1986. Record added to 510k Database: March 2026.

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510k Database

510(k) clearances indexed 175,972

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FDA monthly sync September 21, 2026