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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 the device name listed in this FDA 510(k) record. The listed applicant is Schoelly Fiberoptic GmbH. It received FDA 510(k) clearance on 2016-02-09 under 510(k) 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. The listed applicant is Schoelly Fiberoptic GmbH. The 510(k) number is K151308.

When did Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set receive FDA 510(k) clearance?

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

Who is the listed applicant for Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set?

The FDA 510(k) record lists Schoelly Fiberoptic GmbH as the applicant. This does not by itself establish the device manufacturer.

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 records listing Schoelly Fiberoptic GmbH 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.

K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light SourceK201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))K201970Schoelly Cystoscopes/Hysteroscopes and Accessories

Related Devices (Code: FGA)

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.

K232370Percutaneous Nephroscope SystemKarl Storz SE & CO. KG

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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