Inivox Electrode/Catheter Sys

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K832916 ↗

FDA Product Code

LLE

Device Class

Class III

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Dinamap Vital Signs Monitor Models 9300 and 9320/9340

  Class II

  FDA 510(k) K942700 Active Cleared 1 Mar 1995

• Simplicity Plus

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  FDA 510(k) K831761 Active Cleared 12 Aug 1983

• Dinamap Vital Signs Monitor, Model 8100T

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  FDA 510(k) K874378 Active Cleared 30 Dec 1987

• Iv Sets

  Class II

  FDA 510(k) K811107 Active Cleared 12 Jun 1981

• Dinamap Plus Vital Signs Monoitor

  Class II

  FDA 510(k) K943709 Active Cleared 16 Jun 1995

• Rateminder V Infusion Pump

  Class II

  FDA 510(k) K875174 Active Cleared 29 Mar 1988

See all devices from Critikon Company, LLC →

• What clinical conditions is the Inivox Electrode/Cathéter System intended to address in patients?

  The Inivox Electrode/Cathéter System is designed to manage peripheral vascular disease by delivering electrical stimulation to modulate nerve activity in the spinal cord. It is intended for implanted use to provide therapeutic relief for patients experiencing symptoms related to vascular-related conditions, though it is not an indication for all vascular disorders.

• Is the Inivox Electrode/Cathéter System reusable or intended for single-use, and how is it packaged?

  The Inivox Electrode/Cathéter System is sterile and intended for single-use only, per manufacturer guidelines. It is supplied in a sterile package to ensure surgical-grade sterility, preventing cross-contamination and maintaining safety for implantation.

• Can this device be used in an MRI environment, and what precautions should be taken during handling?

  The Inivox Electrode/Cathéter System is not MRI-safe, meaning it should never be exposed to MRI fields. Handling must follow the manufacturer’s instructions strictly to preserve functionality and ensure patient safety, including proper storage and implantation techniques.

• What regulatory pathway does this device follow, and how was its equivalence determined?

  The Inivox Electrode/Cathéter System follows the FDA 510(k) clearance pathway, classified as a Class III device under the Traditional 510(k) review. Its equivalence was determined through a Substantially Equivalent (SESE) decision, meaning it was found to have the same intended use, technological characteristics, and performance as a legally marketed predicate device.