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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 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 2024-05-07 under 510(k) 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. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K232486.

When did KARL STORZ Monopolar Resectoscopes with HF Cable receive FDA 510(k) clearance?

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

Who is the listed applicant for KARL STORZ Monopolar Resectoscopes with HF Cable?

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 KARL STORZ Monopolar Resectoscopes with HF Cable?

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

Other records listing Karl Storz SE & CO. KG 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.

K261706Endomat Select (UP220)K252800KARL STORZ Endoscopic Accessories for UrologyK254228KARL STORZ Trocars with Valve SealsK260003KARL STORZ Mediastinoscopes and InstrumentsK254242KARL STORZ ICG Imaging System with RUBINA® LensK253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)

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Related Devices (Code: FJL)

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.

K221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc.K230205Veloxion 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.K162979Veloxion 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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