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)

DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A

K-Number: K021179 · 2002-07-05

ApplicantOlympus Optical Co., Ltd.
Decision Date2002-07-05
Product CodeOCY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Optical Co., Ltd.. It received FDA 510(k) clearance on 2002-07-05 under 510(k) number K021179. The device is classified under product code OCY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A?

DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A is a medical device that received FDA 510(k) clearance on 2002-07-05. The listed applicant is Olympus Optical Co., Ltd.. The 510(k) number is K021179.

When did DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A receive FDA 510(k) clearance?

DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A received FDA 510(k) clearance on 2002-07-05, under 510(k) number K021179.

Who is the listed applicant for DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A?

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

What is the FDA product code for DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A?

The FDA product code for DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A is OCY.

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 Optical Co., 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.

K033225EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENTK031305OLYMPUS ULTRASONIC SURGICAL SYSTEMK031648VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VK032092OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPEK031347ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8K024138HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE

View all 22 devices →

Related Devices (Code: OCY)

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.

K153264EasyPass GuidewireMedi-Globe CorporationK131072ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILICColoplast A/SK124052OSTAVI HYDROPHILIC GUIDEWIRELake Region MedicalK123438XENX STONE MANAGEMENT DEVICEXenolith MedicalK123439NEO ERCP GUIDEWIRENeometrics, Inc.K122816AXCESS SOFT TIP WIRE GUIDEWilson-Cook Medical, 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.

↑