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FDA 510(k)

OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER

K-Number: K010591 · 2001-03-15

ApplicantOlympus Optical Co., Ltd.
Decision Date2001-03-15
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER 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 2001-03-15 under 510(k) number K010591. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER?

OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER is a medical device that received FDA 510(k) clearance on 2001-03-15. The listed applicant is Olympus Optical Co., Ltd.. The 510(k) number is K010591.

When did OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER receive FDA 510(k) clearance?

OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER received FDA 510(k) clearance on 2001-03-15, under 510(k) number K010591.

Who is the listed applicant for OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER?

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 OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER?

The FDA product code for OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER is ODG.

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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

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Related Devices (Code: ODG)

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.

K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems CorporationK260428RIVOS™ EUS Access Device (M00553900)Boston Scientific CorporationK251859EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems CorporationK251542InstaFANOnepass Medical , Ltd.K231813Ultrasonic GastrovideoscopeSonoscape Medical Corp.K232518EndoSound Vision System; EVSEndosound, 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.

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