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)

APERTURE

K-Number: K895084 · 1989-10-27

ApplicantCustom Medical Products, Ltd.
Decision Date1989-10-27
Product CodeIZS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

APERTURE is the device name listed in this FDA 510(k) record. The listed applicant is Custom Medical Products, Ltd.. It received FDA 510(k) clearance on 1989-10-27 under 510(k) number K895084. The device is classified under product code IZS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APERTURE?

APERTURE is a medical device that received FDA 510(k) clearance on 1989-10-27. The listed applicant is Custom Medical Products, Ltd.. The 510(k) number is K895084.

When did APERTURE receive FDA 510(k) clearance?

APERTURE received FDA 510(k) clearance on 1989-10-27, under 510(k) number K895084.

Who is the listed applicant for APERTURE?

The FDA 510(k) record lists Custom Medical Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APERTURE?

The FDA product code for APERTURE is IZS.

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 PubMed Literature

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.

PMID: 41807277QT Myopia and Cardiac Safety: Expanding the Aperture of Arrhythmia Assessment in Early Phase Drug Development.Clinical and translational science ()

Other records listing Custom Medical Products, Ltd. 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.

K931417STERILE EQUIPMENT COVERSK931456SURGICAL DRAPE AND GOWN TRAYK930815ABDOMINAL / THORACIC PATIENT DRAPEK931418SURGICAL DRAPEK931455HEAD SHEETK931844CUSTOM PROCEDURE MEDICAL TRAY OR KIT

View all 13 devices →

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.

↑