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)

ENDOEYE HD II

K-Number: K111788 · 2012-01-13

ApplicantOlympus America, Inc.
Decision Date2012-01-13
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDOEYE HD II is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 2012-01-13 under 510(k) number K111788. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOEYE HD II?

ENDOEYE HD II is a medical device that received FDA 510(k) clearance on 2012-01-13. The listed applicant is Olympus America, Inc.. The 510(k) number is K111788.

When did ENDOEYE HD II receive FDA 510(k) clearance?

ENDOEYE HD II received FDA 510(k) clearance on 2012-01-13, under 510(k) number K111788.

Who is the listed applicant for ENDOEYE HD II?

The FDA 510(k) record lists Olympus America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOEYE HD II?

The FDA product code for ENDOEYE HD II is HET.

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 Olympus America, Inc. 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.

K081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK073487OLYMPUS IGM REAGENTK073489OLYMPUS IGA REAGENTK073490OLYMPUS IGG REAGENTK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98K063804OLYMPUS TRIGLYCERIDE TEST SYSTEM

View all 149 devices →

Related Devices (Code: HET)

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.

K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) LimitedK243821i-CutA.M.I. Agency For Medical Innovations GmbHK221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) LimitedK210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope System270surgical , Ltd.

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.

↑