FDA 510(k) Premarket Notification K242841: Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)

Submission Details & Decision

Normalized public record details for 510(k) notification K242841.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K242841

Applicant / Sponsor

ABBOTT MEDICAL

Device Name

Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)

Product Code

GXI

Decision Date

2025-05-27

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Neurology (NE)

Clearance Type

Traditional

Third Party Flag

Date Received

2024-09-19

Related Establishments / Registrations

Boston Scientific Corporation Registration: 1000121056 View Registration
SFM Medical Devices GmbH Registration: 1000632857 View Registration
MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 1030489 View Registration
Viant AS&O Holdings, LLC Registration: 1221485 View Registration
GEOTEC, INC. Registration: 1222773 View Registration
SPECTRA MEDICAL DEVICES, LLC Registration: 1224960 View Registration
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center Registration: 1225687 View Registration
Bausch & Lomb Incorporated Registration: 1313525 View Registration
EPIMED INTERNATIONAL, INC. Registration: 1316297 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
Isomedix Operations, Inc. Registration: 1450662 View Registration
ISOMEDIX OPERATIONS INC Registration: 1526711 View Registration
Abbott Medical Registration: 1627487 View Registration
Epimed International, Inc. Registration: 1643059 View Registration
ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration
MedXL Registration: 1644312 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration
MERIT MEDICAL SYSTEMS, INC. Registration: 1721504 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
CEA Medical Manufacturing, Inc. Registration: 1721983 View Registration
Bausch & Lomb Incorporated Registration: 1920664 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
Isomedix Operations, Inc. Registration: 2030624 View Registration
PRO-TECH DESIGN & MFG., INC. Registration: 2032521 View Registration
Boston Scientific Corporation Registration: 2124215 View Registration
BENCHMARK ELECTRONICS, INC. Registration: 2133786 View Registration
St. Jude Medical, Atrial Fibrillation Division, Inc. Registration: 2182269 View Registration
PMT CORP. Registration: 2182979 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 3003120897 View Registration
Bausch+Lomb Netherlands B.V. Amsterdam Logistics Centre Registration: 3003365815 View Registration
QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration
MINTA MEDICAL LIMITED Registration: 3004617090 View Registration
NISSHA MEDICAL TECHNOLOGIES SAS Registration: 3004762958 View Registration
OSCOR CARIBE LLC Registration: 3004785273 View Registration
ARMOR PLAST LTD Registration: 3005160949 View Registration
St. Jude Medical, Cardiology Division, Inc. Registration: 3005334138 View Registration
Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration
Boston Scientific Neuromodulation Corporation Registration: 3006630150 View Registration
Merit Medical Nederland BV Registration: 3006950086 View Registration
AMPHENOL ALDEN PRODUCTS COMPANY Registration: 3007029079 View Registration
safemed medical devices s.r.o. Registration: 3007221462 View Registration
Boston Scientific Corporation Registration: 3007695959 View Registration
STRYKER MANUFACTURING KALAMAZOO Registration: 3007997036 View Registration
Synergy Health Radeberg GMBH Registration: 3008102042 View Registration
SYMMETRY MEDICAL POLYVAC SAS Registration: 3008534770 View Registration
RIVERSIDE MEDICAL PACKAGING COMPANY LTD Registration: 3008559295 View Registration
STRYKER EMEA Supply Chain Services Registration: 3008837339 View Registration
BIOMERICS Registration: 3008998256 View Registration
LCCS PRODUCTS LIMITED Registration: 3009241989 View Registration
BGS BETA-GAMMA-SERVICE GMBH & CO KG Registration: 3009732568 View Registration
QXMEDICAL, LLC Registration: 3009766315 View Registration
EIRMED, LLC Registration: 3009823392 View Registration
SCIENTIFIC MOLDING CORPORATION LTD. DBA SMC LTD. Registration: 3010034260 View Registration
RBC Development LLC dba RBC Medical Innovations dba Vantage MedTech Registration: 3010126772 View Registration
Synergy Health AST, SRL Registration: 3010273872 View Registration
CUSTOM TUBE MANUFACTURING LLC Registration: 3010966701 View Registration
Avanos Medical, Inc. Registration: 3011270181 View Registration
Merit Medical Canada Ltd. Registration: 3012536737 View Registration
EUROFINS INPAC MEDIZINTECHNIK GMBH Registration: 3013111980 View Registration
ARVATO Netherlands B.V. Registration: 3013302242 View Registration
Medline Industries, LP - Mexicali (MXC) Registration: 3015173212 View Registration
Merit Medical UK Limited Registration: 3015309643 View Registration
Exel Inc. Registration: 3015443199 View Registration
AUSA Medical Device Pvt Ltd Registration: 3015924373 View Registration
Stryker Instruments Registration: 3015967359 View Registration
NEUROONE MEDICAL TECHNOLOGIES CORP. Registration: 3016438686 View Registration
Schneider ASR B.V. Registration: 3016678045 View Registration
STRATUS MEDICAL Registration: 3017423051 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
BAYLIS MEDICAL TECHNOLOGIES INC. Registration: 3020968442 View Registration
ARVATO USA LLC Registration: 3021008900 View Registration
Bausch & Lomb Incorporated Registration: 3029990829 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
Merit Medical Australia Pty Ltd. Registration: 3033589330 View Registration
RBC Development LLC dba RBC Medical Innovations dba Vantage MedTech Registration: 3043527620 View Registration
STRYKER LEIBINGER GMBH & CO. KG Registration: 8010177 View Registration
DIROS TECHNOLOGY, INC. Registration: 8043398 View Registration
PAJUNK GMBH MEDIZINTECHNOLOGIE Registration: 9611612 View Registration
Sterigenics EO Canada, Inc. Registration: 9611665 View Registration
MERIT MEDICAL IRELAND, LTD Registration: 9616662 View Registration
Boston Scientific Limited Registration: 9616693 View Registration
Venusa de Mexico S. de R.L de C.V Registration: 9680001 View Registration
Avent S. de R.L. de C.V. Registration: 9680425 View Registration

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