Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2019-08-30 under approval 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. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K190449.

When was Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head approved by the FDA?

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 approval number K190449.

What company makes 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 manufactured by Olympus Medical Systems Corp..

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.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING

Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Olympus Medical Systems Corp.

K153773Disposal Lens Cleaning Sheath K160098Single Use Aspiration Needle NA-U401SX K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 K151743THUNDERBEAT Open Fine Jaw K153625Single Use Injector NM600/610 K143153EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V

View all 77 devices →

Related Devices (Code: FET)

K160044Image1 SPIES SystemKarl Storz Endoscopy America, Inc. K1728174K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EAOlympus Medical Systems Corp. K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. K161204ENDOCAM Flex HD Camera System 5521Richard Wolf Medical Instruments Corporation K182696Telepack X LEDKARL STORZ Endoscopy-America, Inc. K180583LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEADRichard Wolf Medical Instruments 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.

↑