Owl Cannulae

510(k) Number

K102566 ↗

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).

• RADIONICS MICROELECTRODE KIT by Radionics, Inc.
• CN-10 by Boston Scientific Neuromodulation
• TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL by Top Corp.
• VAXIOM FAMILY OF RF LESION PROBES & ELEC by Progress Mankind Technology
• SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE, FLEXIBLE by Radionics, Inc.
• Coolief* Cooled RF Probe by Halyard Health
• PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS by Baylis Medical Co., Inc.
• INTRACEPT Intraosseous Nerve Ablation System by Relievant Medsystems, Inc.
• Vesta NLT-150-20-10-CS by Stratus Medical LLC
• Nimbus NIM-050-10BB by Stratus Medical LLC

• 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. →