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)

Visual-ICE Cryoablation System

K-Number: K230551 · 2023-08-08

ApplicantBoston Scientific Corporation
Decision Date2023-08-08
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Visual-ICE Cryoablation System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-08-08 under approval number K230551. 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 Visual-ICE Cryoablation System?

Visual-ICE Cryoablation System is a medical device that received FDA 510(k) clearance on 2023-08-08. It is manufactured by Boston Scientific Corporation. The 510(k) number is K230551.

When was Visual-ICE Cryoablation System approved by the FDA?

Visual-ICE Cryoablation System received FDA 510(k) clearance on 2023-08-08, under approval number K230551.

What company makes Visual-ICE Cryoablation System?

Visual-ICE Cryoablation System is manufactured by Boston Scientific Corporation.

What is the FDA product code for Visual-ICE Cryoablation System?

The FDA product code for Visual-ICE Cryoablation System is GEH.

Related Clinical Trials

NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05150197 Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease RECRUITING NCT07409545 Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes NOT_YET_RECRUITING NCT07598604 Early Mobilization and Equinus Correction in Spastic Cerebral Palsy NOT_YET_RECRUITING NCT04674969 Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature RECRUITING

Other Devices by Boston Scientific Corporation

K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete K163174Emerge PTCA Dilatation Catheter K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018 K162404Express SD Biliary Monorail Premounted Stent System K160823NC Quantum Apex PTCA Dilatation Catheter K160514OptiCross 18, 30 MHz Peripheral Imaging Catheter

View all 176 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.

↑