FDA 510(k)

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

K-Number: K052452 · 2005-09-21

ApplicantOlympus Medical Systems Corporation

Decision Date2005-09-21

Product CodeEOB

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT 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 2005-09-21 under 510(k) number K052452. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT?

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT is a medical device that received FDA 510(k) clearance on 2005-09-21. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K052452.

When did VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT receive FDA 510(k) clearance?

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT received FDA 510(k) clearance on 2005-09-21, under 510(k) number K052452.

Who is the listed applicant for VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT?

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 VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT?

The FDA product code for VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT is EOB.

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Other records listing Olympus Medical Systems Corporation as applicant

K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)K260824Gastrointestinal Videoscope Olympus GIF-2T1500 K260856Disposable Distal Attachment D-201-13404 K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K261260HD Camera Head OLYMPUS CH-S200-08-LB K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

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Related Devices (Code: EOB)

K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)Karl Storz SE & CO. KG K261544Hydro Irrigation SystemStryker Instruments K254133ENTity USB Videoscope SystemOptim, LLC K253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems Corporation K241731Outlook Surgical Versa One System (8900139)Resnent, LLC

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.