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FDA 510(k)

ARM AUTOMATIC REPROCESSING MACHINE

K-Number: K013713 · 2002-07-15

ApplicantAlcavis International Incorporated
Decision Date2002-07-15
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ARM AUTOMATIC REPROCESSING MACHINE is the device name listed in this FDA 510(k) record. The listed applicant is Alcavis International Incorporated. It received FDA 510(k) clearance on 2002-07-15 under 510(k) number K013713. The device is classified under product code LIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARM AUTOMATIC REPROCESSING MACHINE?

ARM AUTOMATIC REPROCESSING MACHINE is a medical device that received FDA 510(k) clearance on 2002-07-15. The listed applicant is Alcavis International Incorporated. The 510(k) number is K013713.

When did ARM AUTOMATIC REPROCESSING MACHINE receive FDA 510(k) clearance?

ARM AUTOMATIC REPROCESSING MACHINE received FDA 510(k) clearance on 2002-07-15, under 510(k) number K013713.

Who is the listed applicant for ARM AUTOMATIC REPROCESSING MACHINE?

The FDA 510(k) record lists Alcavis International Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARM AUTOMATIC REPROCESSING MACHINE?

The FDA product code for ARM AUTOMATIC REPROCESSING MACHINE is LIF.

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

Related Devices (Code: LIF)

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.

K091360CLEARFLUX DIALYZER REPROCESSING SYSTEMNovaflux TechnologiesK043126ASSIST HEADER CLEANERAlcavis International, Inc.K040660STERICHEK GLUTARALDEHYDE REAGENT STRIPSHach CompanyK033505RENACLEAN SH DIALYZER CLEANING SYSTEMMinntech Corp.K024076MAKY 21.1 DIALYZER REPROCESSING SYSTEMHdc Maquinolas, LLCK992016AMUKIN DAmuchina Intl., 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.

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