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FDA 510(k)

INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set

K-Number: K153272 · 2016-07-09

ApplicantRelievant Medsystems
Decision Date2016-07-09
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set is a medical device manufactured by Relievant Medsystems. It received FDA 510(k) clearance on 2016-07-09 under approval number K153272. 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 INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set?

INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set is a medical device that received FDA 510(k) clearance on 2016-07-09. It is manufactured by Relievant Medsystems. The 510(k) number is K153272.

When was INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set approved by the FDA?

INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set received FDA 510(k) clearance on 2016-07-09, under approval number K153272.

What company makes INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set?

INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set is manufactured by Relievant Medsystems.

What is the FDA product code for INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set?

The FDA product code for INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set is GXI.

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Other Devices by Relievant Medsystems

K171143Relievant Medsystems RF Generator K170827INTRACEPT Intraosseous Nerve Ablation System K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator

Related Devices (Code: GXI)

K163236COOLIEF Cooled Radiofrequency KitHalyard Health, Inc. K152642LCCS Disposable RF Electrode, LCCS Reusable RF ElectrodeLccs Products Limited K170827INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems K170708OWL RF INSULATED CANNULAEDiros Technology, Inc. K163461Coolief* Cooled RF ProbeHalyard Health, Inc. K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems

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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