Atlas FDA

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

FDA 510(k) clearance K242841 · decided 2025-05-27

Clearance details

K-number
K242841
Device name
Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
Applicant
ABBOTT MEDICAL
Decision
Substantially Equivalent
Date received
2024-09-19
Decision date
2025-05-27
Days to decision
250 days
Clearance type
Traditional
Product code
GXI
Device class
2
Regulation number
882.4725
Medical specialty
Neurology
Advisory committee
Neurology
Location
Plano, TX, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Disposable Radiofrequency Cannula (K253907)ABBOTT MEDICAL2026-04-16
STAR RF Ablation System (K251802)Merit Medical Systems, Inc.2026-02-13
OneRF Trigeminal Nerve Radiofrequency Probes (K251243)Neuroone Medical Technologies Corp.2025-08-15
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) (K250213)Stryker Instruments2025-05-15
RF Cannula (K241367)Shanghai Samedical & Plastic Instruments Co., Ltd.2025-01-23
Intracept Intraosseous Nerve Ablation System (K222281)Relievant Medsystems, Inc.2022-10-26
Intracept Intraosseous Nerve Ablation System (K213836)Relievant Medsystems, Inc.2022-03-11
COOLIEF Cooled Radiofrequency Kit Advanced (K203066)Avanos Medical, Inc.2020-12-22
Vesta RF Cannula (K190259)Biomerics2020-02-07
LCCS VC-S RF Cannula (K191293)Lccs Products Limited2020-01-24
Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator (K190504)Relievant Medsystems2019-05-03
Nitinol Thermocouple (TCN) Electrode (K183177)Boston Scientific Corporation2019-03-08

Recalls involving this device

No recalls on record reference this clearance.

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