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FDA 510(k)

MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM

K-Number: K090210 · 2009-07-29

ApplicantOlympus Medical Systems Corporation
Decision Date2009-07-29
Product CodeNEZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE 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 2009-07-29 under 510(k) number K090210. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM?

MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 2009-07-29. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K090210.

When did MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM received FDA 510(k) clearance on 2009-07-29, under 510(k) number K090210.

Who is the listed applicant for MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE 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 MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM?

The FDA product code for MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM is NEZ.

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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)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: NEZ)

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.

K252617MiroCam® Capsule Endoscope SystemIntromedic Co., Ltd.K252480CE Deliver (DLV)CapsoVision, Inc.K242643CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc.K240276PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareGiven Imaging Ltd. (D.B.A. Medtronic)K233229NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherAnx Robotica CorporationK230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic)

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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