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FDA 510(k)

FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)

K-Number: K233425 · 2024-01-25

ApplicantSutter Medizintechnik GmbH
Decision Date2024-01-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) is a medical device manufactured by Sutter Medizintechnik GmbH. It received FDA 510(k) clearance on 2024-01-25 under approval number K233425. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)?

FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) is a medical device that received FDA 510(k) clearance on 2024-01-25. It is manufactured by Sutter Medizintechnik GmbH. The 510(k) number is K233425.

When was FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) approved by the FDA?

FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) received FDA 510(k) clearance on 2024-01-25, under approval number K233425.

What company makes FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)?

FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) is manufactured by Sutter Medizintechnik GmbH.

What is the FDA product code for FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)?

The FDA product code for FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) is GEI.

Related Clinical Trials

NCT06011252 Pacing Characteristics of a Conventional Bipolar ACTIVE_NOT_RECRUITING NCT06723743 Transcutaneous Vagus Nerve Stimulation for Attention and Memory RECRUITING NCT07518745 TMS for iEEG Monitoring Recordings ENROLLING_BY_INVITATION NCT07563257 Comparative Evaluation of Optrell and Octaray Mapping Catheters for Conduction Block Confirmation and Voltage Assessment During Atrial Ablation NOT_YET_RECRUITING NCT04675398 Adaptive Deep Brain Stimulation to Improve Motor and Gait Functions in Parkinson's Disease ACTIVE_NOT_RECRUITING NCT06649357 Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate RECRUITING

Other Devices by Sutter Medizintechnik GmbH

K171869Sutter CURIS RF Generator K192128Sutter Arrowtip Monopolar Electrodes K191732Sutter RaVoR Bipolar Electrodes K193587Sutter Swyng non-stick bipolar forceps, single-use K251813CURIS II RF Generator (REF 360100-05)

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

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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