FDA 510(k)

BARRX CHANNEL RFA ENDOSCOPIC CATHETER

K-Number: K130623 · 2013-07-26

Decision Date2013-07-26

Product CodeKNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

BARRX CHANNEL RFA ENDOSCOPIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2013-07-26 under 510(k) number K130623. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARRX CHANNEL RFA ENDOSCOPIC CATHETER?

BARRX CHANNEL RFA ENDOSCOPIC CATHETER is a medical device that received FDA 510(k) clearance on 2013-07-26. The listed applicant is Covidien, LLC. The 510(k) number is K130623.

When did BARRX CHANNEL RFA ENDOSCOPIC CATHETER receive FDA 510(k) clearance?

BARRX CHANNEL RFA ENDOSCOPIC CATHETER received FDA 510(k) clearance on 2013-07-26, under 510(k) number K130623.

Who is the listed applicant for BARRX CHANNEL RFA ENDOSCOPIC CATHETER?

The FDA 510(k) record lists Covidien, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARRX CHANNEL RFA ENDOSCOPIC CATHETER?

The FDA product code for BARRX CHANNEL RFA ENDOSCOPIC CATHETER is KNS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Covidien, LLC as applicant

K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated K253527Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)K253984Instrument Exit Point on Touch Surgery™ Aide K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)K251025Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT

View all 70 devices →

Related Devices (Code: KNS)

K262460Rezum SystemBoston Scientific K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation

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.