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FDA 510(k)

ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2

K-Number: K063786 · 2007-03-05

ApplicantOlympus Medical Systems Corporation
Decision Date2007-03-05
Product CodeFCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 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 2007-03-05 under 510(k) number K063786. The device is classified under product code FCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2?

ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 is a medical device that received FDA 510(k) clearance on 2007-03-05. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K063786.

When did ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 receive FDA 510(k) clearance?

ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 received FDA 510(k) clearance on 2007-03-05, under 510(k) number K063786.

Who is the listed applicant for ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2?

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 ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2?

The FDA product code for ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 is FCX.

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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

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Related Devices (Code: FCX)

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.

K262152VS-370CF, VS-370CTVISION MEDICAL Co., Ltd.K240847MedicCO2LON (MedicCO2LON)Ide Vision, Ltd.K230474EVA5 InsufflatorPalliare , Ltd.K202922END 200 Endoscopic TubesetPalliare , Ltd.K201096CO2mbiLEDKarl Storz Endoscopy America, Inc.K190985BAROnova Insufflation System, BAROnova Accessory KitBaronova, 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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