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FDA 510(k)

Percutaneous Nephroscope System

K-Number: K232370 · 2024-05-01

ApplicantKarl Storz SE & CO. KG
Decision Date2024-05-01
Product CodeFGA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Percutaneous Nephroscope System is a medical device manufactured by Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2024-05-01 under approval number K232370. 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 Percutaneous Nephroscope System?

Percutaneous Nephroscope System is a medical device that received FDA 510(k) clearance on 2024-05-01. It is manufactured by Karl Storz SE & CO. KG. The 510(k) number is K232370.

When was Percutaneous Nephroscope System approved by the FDA?

Percutaneous Nephroscope System received FDA 510(k) clearance on 2024-05-01, under approval number K232370.

What company makes Percutaneous Nephroscope System?

Percutaneous Nephroscope System is manufactured by Karl Storz SE & CO. KG.

What is the FDA product code for Percutaneous Nephroscope System?

The FDA product code for Percutaneous Nephroscope System is FGA.

Related Clinical Trials

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Related PubMed Literature

PMID: 25499024 Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel meeting regarding the Lutonix® drug coated balloon. Cardiovascular revascularization medicine : including molecular interventions (2014)

Other Devices by Karl Storz SE & CO. KG

K180735Endomat Select K201355Endomat Select, IBS Shaver Software, License K192090CMOS Video Rhino-Laryngoscope SSU K192523CMOS Video Esophagoscope SSU K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit K232857KARL STORZ ICG Imaging System

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Related Devices (Code: FGA)

K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetSchoelly Fiberoptic GmbH

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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