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)

ICEfx Cryoablation System (FPRCH8000-02)

K-Number: K234002 · 2024-03-13

ApplicantBoston Scientific
Decision Date2024-03-13
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ICEfx Cryoablation System (FPRCH8000-02) is a medical device manufactured by Boston Scientific. It received FDA 510(k) clearance on 2024-03-13 under approval number K234002. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICEfx Cryoablation System (FPRCH8000-02)?

ICEfx Cryoablation System (FPRCH8000-02) is a medical device that received FDA 510(k) clearance on 2024-03-13. It is manufactured by Boston Scientific. The 510(k) number is K234002.

When was ICEfx Cryoablation System (FPRCH8000-02) approved by the FDA?

ICEfx Cryoablation System (FPRCH8000-02) received FDA 510(k) clearance on 2024-03-13, under approval number K234002.

What company makes ICEfx Cryoablation System (FPRCH8000-02)?

ICEfx Cryoablation System (FPRCH8000-02) is manufactured by Boston Scientific.

What is the FDA product code for ICEfx Cryoablation System (FPRCH8000-02)?

The FDA product code for ICEfx Cryoablation System (FPRCH8000-02) is GEH.

Related Clinical Trials

NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT05501873 Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System ACTIVE_NOT_RECRUITING NCT04674969 Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature RECRUITING NCT04200937 IT Matters: The Erectile Restoration Registry ENROLLING_BY_INVITATION NCT06982235 Stone and Laser Therapies Post-Market Study (SALT) RECRUITING NCT01719055 RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain RECRUITING

Other Devices by Boston Scientific

K160751Symphion Endoscope and Symphion Cervical Sheath DEN150040WallFlex Biliary RX Fully Covered Stent System RMV K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle K180068ORISE Gel K180864WATCHMAN TruSeal Access System

View all 43 devices →

Related Devices (Code: GEH)

K162695truFreeze SystemCSA Medical, Inc. K162599IcePearl 2.1 CX L, IceForce 2.1 CX LGalil Medical , Ltd. K161480R2 Dermal Cooling SystemR2 Dermatology K161294Compound W Wart Removal System Dual PowerMedtech Products, Inc. K161615AccurettH&O Equipments, Nv/Sa K161557truFreeze SystemCSA Medical, 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.

↑