Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Cool-tip RF Ablation System E Series

K-Number: K203150 · 2022-02-25

ApplicantCovidien, LLC
Decision Date2022-02-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cool-tip RF Ablation System E Series is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2022-02-25 under approval number K203150. 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 Cool-tip RF Ablation System E Series?

Cool-tip RF Ablation System E Series is a medical device that received FDA 510(k) clearance on 2022-02-25. It is manufactured by Covidien, LLC. The 510(k) number is K203150.

When was Cool-tip RF Ablation System E Series approved by the FDA?

Cool-tip RF Ablation System E Series received FDA 510(k) clearance on 2022-02-25, under approval number K203150.

What company makes Cool-tip RF Ablation System E Series?

Cool-tip RF Ablation System E Series is manufactured by Covidien, LLC.

What is the FDA product code for Cool-tip RF Ablation System E Series?

The FDA product code for Cool-tip RF Ablation System E Series is GEI.

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT06762717 FARAPULSE™ Pulsed Field Ablation System RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025)

Other Devices by Covidien, LLC

K163105Emprint Ablation System K163098Tri-Staple 2.0 Intelligent Cartridge K160290Valleylab REM Polyhesive Infant Patient Return Electrode K160654GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) K152794Cytosponge Cell Collection Device K160360Barrx FLEX RFA Energy Generator

View all 57 devices →

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.

↑