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FDA 510(k)

ACCULITE

K-Number: K872841 · 1987-08-12

ApplicantMedical Alignment Systems
Decision Date1987-08-12
Product CodeIWE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACCULITE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Alignment Systems. It received FDA 510(k) clearance on 1987-08-12 under 510(k) number K872841. The device is classified under product code IWE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCULITE?

ACCULITE is a medical device that received FDA 510(k) clearance on 1987-08-12. The listed applicant is Medical Alignment Systems. The 510(k) number is K872841.

When did ACCULITE receive FDA 510(k) clearance?

ACCULITE received FDA 510(k) clearance on 1987-08-12, under 510(k) number K872841.

Who is the listed applicant for ACCULITE?

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

What is the FDA product code for ACCULITE?

The FDA product code for ACCULITE is IWE.

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 Medical Alignment Systems 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.

K923619ACCULITE SSLK884787ACCULITE-PPL 5

Related Devices (Code: IWE)

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.

K973162DUAL RADIATION TARGETING SYSTEM DRTS DRAPEHogan & HartsonK955236GREEN TEC-2100Medtec, Inc.K954414CENTRALITE BACKPOINTERDiacor, Inc.K950293TEC-2110 GREEN LASER MODEL MT-HNGMedtec, Inc.K950112CENTRALITE(R)-DLL SERIESDiacor, Inc.K951601MED-TEC STRING RETICLE TRAYMedtec, Inc.

Official Source

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

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