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)

Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set

K-Number: K151308 · 2016-02-09

ApplicantSchoelly Fiberoptic GmbH
Decision Date2016-02-09
Product CodeFGA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set is a medical device manufactured by Schoelly Fiberoptic GmbH. It received FDA 510(k) clearance on 2016-02-09 under approval number K151308. The device is classified under product code FGA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set?

Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set is a medical device that received FDA 510(k) clearance on 2016-02-09. It is manufactured by Schoelly Fiberoptic GmbH. The 510(k) number is K151308.

When was Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set approved by the FDA?

Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set received FDA 510(k) clearance on 2016-02-09, under approval number K151308.

What company makes Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set?

Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set is manufactured by Schoelly Fiberoptic GmbH.

What is the FDA product code for Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set?

The FDA product code for Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set is FGA.

Other Devices by Schoelly Fiberoptic GmbH

K201970Schoelly Cystoscopes/Hysteroscopes and Accessories 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: FGA)

K232370Percutaneous Nephroscope SystemKarl Storz SE & CO. KG

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.

↑