Atlas FDA

SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE

FDA 510(k) clearance K034012 · decided 2004-03-16

Clearance details

K-number
K034012
Device name
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2003-12-24
Decision date
2004-03-16
Days to decision
83 days
Clearance type
Traditional
Product code
GXI
Device class
2
Regulation number
882.4725
Medical specialty
Neurology
Advisory committee
Neurology
Location
Andover, MA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Smith & Nephew

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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
Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) (K242841)ABBOTT MEDICAL2025-05-27
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

Recalls involving this device

RecordFirmDate
RF Denervation Probe, 5cm, temperature sensing electrodes designed for use in radiofrequen recall (Z-0662-2007)Smith & Nephew, Inc. Endoscopy Division2007-03-29
RF Denervation Probe, 10 cm, temperature sensing electrodes designed for use in radiofrequ recall (Z-0663-2007)Smith & Nephew, Inc. Endoscopy Division2007-03-29
RF Denervation Probe, 15 cm, temperature sensing electrodes designed for use in radiofrequ recall (Z-0664-2007)Smith & Nephew, Inc. Endoscopy Division2007-03-29

PMA approvals by this applicant

RecordFirmDate
Ascension MCP (P000057/S013)Smith & Nephew, Inc.2025-12-31
ASCENSION MCP (P000057/S014)Smith & Nephew, Inc.2025-08-05
R3™ Delta Ceramic Acetabular System (P150030/S049)Smith & Nephew, Inc.2025-04-17
R3 DELTA CERAMIC HIP SYSTEM (P150030/S048)Smith & Nephew, Inc.2025-03-03
R3 Delta Ceramic Hip System (P150030/S045)Smith & Nephew, Inc.2025-02-28
R3™ Delta Ceramic Acetabular System (P150030/S047)Smith & Nephew, Inc.2025-02-21
R3™ Delta Ceramic Acetabular System (P150030/S046)Smith & Nephew, Inc.2025-01-16
BIRMINGHAM HIP™ RESURFACING (BHR) SYSTEM (P040033/S039)Smith & Nephew, Inc.2025-01-10