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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 the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2024-05-01 under 510(k) 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. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K232370.

When did Percutaneous Nephroscope System receive FDA 510(k) clearance?

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

Who is the listed applicant for Percutaneous Nephroscope System?

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Percutaneous Nephroscope System?

The FDA product code for Percutaneous Nephroscope System is FGA.

Other records listing Karl Storz SE & CO. KG as applicant

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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.

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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