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FDA 510(k)

Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head

K-Number: K190449 · 2019-08-30

ApplicantOlympus Medical Systems Corp.
Decision Date2019-08-30
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2019-08-30 under 510(k) number K190449. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head?

Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head is a medical device that received FDA 510(k) clearance on 2019-08-30. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K190449.

When did Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head receive FDA 510(k) clearance?

Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head received FDA 510(k) clearance on 2019-08-30, under 510(k) number K190449.

Who is the listed applicant for Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head?

The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head?

The FDA product code for Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head is FET.

Other records listing Olympus Medical Systems Corp. 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.

K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)K261260HD Camera Head OLYMPUS CH-S200-08-LBK260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

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Related Devices (Code: FET)

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.

K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee Video Processing Unit (PV-003)Proverum LimitedK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm 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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