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FDA 510(k)

KARL STORZ Monopolar Resectoscopes with HF Cable

K-Number: K232486 · 2024-05-07

ApplicantKarl Storz SE & CO. KG
Decision Date2024-05-07
Product CodeFJL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ Monopolar Resectoscopes with HF Cable is a medical device manufactured by Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2024-05-07 under approval number K232486. The device is classified under product code FJL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ Monopolar Resectoscopes with HF Cable?

KARL STORZ Monopolar Resectoscopes with HF Cable is a medical device that received FDA 510(k) clearance on 2024-05-07. It is manufactured by Karl Storz SE & CO. KG. The 510(k) number is K232486.

When was KARL STORZ Monopolar Resectoscopes with HF Cable approved by the FDA?

KARL STORZ Monopolar Resectoscopes with HF Cable received FDA 510(k) clearance on 2024-05-07, under approval number K232486.

What company makes KARL STORZ Monopolar Resectoscopes with HF Cable?

KARL STORZ Monopolar Resectoscopes with HF Cable is manufactured by Karl Storz SE & CO. KG.

What is the FDA product code for KARL STORZ Monopolar Resectoscopes with HF Cable?

The FDA product code for KARL STORZ Monopolar Resectoscopes with HF Cable is FJL.

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Related Devices (Code: FJL)

K162979Veloxion SystemCorinth Medtech, Inc. K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management BagsCorinth Medtech, Inc. K190099Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue CatchCorinth Medtech, Inc. K221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc. K230205Veloxion SystemCorinth Medtech, 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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