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FDA 510(k)

NEUROTHERM RF CANNULA

K-Number: K994344 · 2000-03-21

ApplicantRocket Medical Plc
Decision Date2000-03-21
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROTHERM RF CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Rocket Medical Plc. It received FDA 510(k) clearance on 2000-03-21 under 510(k) number K994344. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROTHERM RF CANNULA?

NEUROTHERM RF CANNULA is a medical device that received FDA 510(k) clearance on 2000-03-21. The listed applicant is Rocket Medical Plc. The 510(k) number is K994344.

When did NEUROTHERM RF CANNULA receive FDA 510(k) clearance?

NEUROTHERM RF CANNULA received FDA 510(k) clearance on 2000-03-21, under 510(k) number K994344.

Who is the listed applicant for NEUROTHERM RF CANNULA?

The FDA 510(k) record lists Rocket Medical Plc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROTHERM RF CANNULA?

The FDA product code for NEUROTHERM RF CANNULA is GXI.

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Other records listing Rocket Medical Plc 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.

K210509Rocket Platinum Cured CathterK163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitK162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitK152105Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetK123033ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE BK052365CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE

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Related Devices (Code: GXI)

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.

K253907Disposable Radiofrequency CannulaABBOTT MEDICALK251802STAR RF Ablation SystemMerit Medical Systems, Inc.K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)ABBOTT MEDICALK250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker InstrumentsK241367RF CannulaShanghai Samedical & Plastic Instruments Co., Ltd.

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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