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)

EVIS EXERAII 180 SYSTEM

K-Number: K100584 · 2010-07-02

ApplicantOlympus Medical Systems Corporation
Decision Date2010-07-02
Product CodeNWB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EVIS EXERAII 180 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2010-07-02 under 510(k) number K100584. The device is classified under product code NWB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVIS EXERAII 180 SYSTEM?

EVIS EXERAII 180 SYSTEM is a medical device that received FDA 510(k) clearance on 2010-07-02. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K100584.

When did EVIS EXERAII 180 SYSTEM receive FDA 510(k) clearance?

EVIS EXERAII 180 SYSTEM received FDA 510(k) clearance on 2010-07-02, under 510(k) number K100584.

Who is the listed applicant for EVIS EXERAII 180 SYSTEM?

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

What is the FDA product code for EVIS EXERAII 180 SYSTEM?

The FDA product code for EVIS EXERAII 180 SYSTEM is NWB.

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 Medical Systems Corporation 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.

K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)K260824Gastrointestinal Videoscope Olympus GIF-2T1500K260856Disposable Distal Attachment D-201-13404K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K261260HD Camera Head OLYMPUS CH-S200-08-LBK252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

View all 86 devices →

Related Devices (Code: NWB)

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.

K222020HD-550 Video Endoscope SystemSonoscape Medical Corp.K211882HD-550 Video Endoscope SystemSonoscape Medical Corp.K173921HD-500 Video Endoscope SystemSonoscape Medical Corp.K090980HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015LOlympus Winter & Ibe GmbHK072957EVIS EXERA II 180 SYSTEMOlympus Medical Systems CorporationK062049EVIS EXERA II 180 SYSTEMOlympus Medical Systems Corporation

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.

↑