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FDA 510(k)

EVIS EXERA 180 SYSTEM

K-Number: K061313 · 2006-08-31

ApplicantOlympus Medical Systems Corporation
Decision Date2006-08-31
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EVIS EXERA 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 2006-08-31 under 510(k) number K061313. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVIS EXERA 180 SYSTEM?

EVIS EXERA 180 SYSTEM is a medical device that received FDA 510(k) clearance on 2006-08-31. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K061313.

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

EVIS EXERA 180 SYSTEM received FDA 510(k) clearance on 2006-08-31, under 510(k) number K061313.

Who is the listed applicant for EVIS EXERA 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 EXERA 180 SYSTEM?

The FDA product code for EVIS EXERA 180 SYSTEM is EOQ.

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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)K260856Disposable Distal Attachment D-201-13404K260824Gastrointestinal Videoscope Olympus GIF-2T1500K261183EVIS 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

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Related Devices (Code: EOQ)

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.

K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/SK2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm 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.

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