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FDA 510(k)

TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))

K-Number: K201617 · 2021-03-12

ApplicantSchoelly Fiberoptic GmbH
Decision Date2021-03-12
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) is a medical device manufactured by Schoelly Fiberoptic GmbH. It received FDA 510(k) clearance on 2021-03-12 under approval number K201617. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))?

TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) is a medical device that received FDA 510(k) clearance on 2021-03-12. It is manufactured by Schoelly Fiberoptic GmbH. The 510(k) number is K201617.

When was TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) approved by the FDA?

TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) received FDA 510(k) clearance on 2021-03-12, under approval number K201617.

What company makes TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))?

TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) is manufactured by Schoelly Fiberoptic GmbH.

What is the FDA product code for TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))?

The FDA product code for TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) is HET.

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Related PubMed Literature

PMID: 40624055 Establishment of a clinical workflow for in vivo Raman spectroscopy during head and neck cancer surgery. Scientific reports (2025)

Other Devices by Schoelly Fiberoptic GmbH

K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set K201970Schoelly Cystoscopes/Hysteroscopes and Accessories K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)

Related Devices (Code: HET)

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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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