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FDA 510(k)

Schoelly Cystoscopes/Hysteroscopes and Accessories

K-Number: K201970 · 2020-10-08

ApplicantSchoelly Fiberoptic GmbH
Decision Date2020-10-08
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Schoelly Cystoscopes/Hysteroscopes and Accessories is a medical device manufactured by Schoelly Fiberoptic GmbH. It received FDA 510(k) clearance on 2020-10-08 under approval number K201970. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Schoelly Cystoscopes/Hysteroscopes and Accessories?

Schoelly Cystoscopes/Hysteroscopes and Accessories is a medical device that received FDA 510(k) clearance on 2020-10-08. It is manufactured by Schoelly Fiberoptic GmbH. The 510(k) number is K201970.

When was Schoelly Cystoscopes/Hysteroscopes and Accessories approved by the FDA?

Schoelly Cystoscopes/Hysteroscopes and Accessories received FDA 510(k) clearance on 2020-10-08, under approval number K201970.

What company makes Schoelly Cystoscopes/Hysteroscopes and Accessories?

Schoelly Cystoscopes/Hysteroscopes and Accessories is manufactured by Schoelly Fiberoptic GmbH.

What is the FDA product code for Schoelly Cystoscopes/Hysteroscopes and Accessories?

The FDA product code for Schoelly Cystoscopes/Hysteroscopes and Accessories is HIH.

Other Devices by Schoelly Fiberoptic GmbH

K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) 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: HIH)

K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal DeviceSmith & Nephew, Inc. K160751Symphion Endoscope and Symphion Cervical SheathBoston Scientific K160510MAKO 7Nvision Medical Corporation K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc. K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, 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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