Owl Rf Probes

510(k) Number

K110593 ↗

FDA product code

GXI

Device class

Class II

Regulation

21 CFR Part 882.4725

Advisory committee

Neurology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code GXI (Probe, Radiofrequency Lesion).

• Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator by Relievant Medsystems, Inc.
• THE STORZ BIPOLAR PENCIL AND CORD by Storz Instrument Co.
• Vesta NLT-100-18-10-BB by Stratus Medical LLC
• STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE by Stryker Instruments
• Vesta NLT-50-22-10-BB by Stratus Medical LLC
• TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC by Top Corp.
• BMC RF CANNULA by Baylis Medical Co., Inc.
• CP-10 by Boston Scientific Neuromodulation
• SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE by Smith & Nephew, Inc.
• INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set by Relievant Medsystems, Inc.

• OWL GD-Pad Patient Return Electrode (Split Type, Non-Corded)

  Class IIb

  CE/MDR

• OWL GD-Pad Patient Return Electrode (Split Type, Corded)

  Class IIb

  CE/MDR

• OWL GD-Pad Patient Return Electrode (Corded)

  Class IIb

  CE/MDR

• OWL GD-Pad Patient Return Electrode (Non-Corded)

  Class IIb

  CE/MDR

See all devices from Diros Technology, Inc. →