Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MCGHAN TISSUE EXPANDER

K-Number: K843704 · 1984-10-31

ApplicantMcghan Medical Corp.
Decision Date1984-10-31
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

MCGHAN TISSUE EXPANDER is the device name listed in this FDA 510(k) record. The listed applicant is Mcghan Medical Corp.. It received FDA 510(k) clearance on 1984-10-31 under 510(k) number K843704. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCGHAN TISSUE EXPANDER?

MCGHAN TISSUE EXPANDER is a medical device that received FDA 510(k) clearance on 1984-10-31. The listed applicant is Mcghan Medical Corp.. The 510(k) number is K843704.

When did MCGHAN TISSUE EXPANDER receive FDA 510(k) clearance?

MCGHAN TISSUE EXPANDER received FDA 510(k) clearance on 1984-10-31, under 510(k) number K843704.

Who is the listed applicant for MCGHAN TISSUE EXPANDER?

The FDA 510(k) record lists Mcghan Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MCGHAN TISSUE EXPANDER?

The FDA product code for MCGHAN TISSUE EXPANDER is LCJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mcghan Medical Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K873476MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURSK873475MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURSK870754MCGHAN TISSUE EXPANDER FILL SYSTEMK864184MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGNK864185MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGNK862203MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER

View all 14 devices →

Related Devices (Code: LCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254126Natrelle 133S Tissue ExpandersAbbVieK242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsMentor Worldwide, LLCK243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLCK241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLCK211676Motiva Flora SmoothSilk Tissue ExpanderMotiva USA, LLCK214124AlloX2 Pro Tissue ExpandersSientra, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑