510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K832916Substantially Equivalent

Inivox Electrode/catheter Sys

Critikon Company, LLC, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832916 is the FDA 510(k) clearance record for INIVOX ELECTRODE/CATHETER SYS, a class III device, cleared for Critikon Company, LLC on under FDA product code LLE (Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease). FDA records list 51 510(k) clearances for Critikon Company, LLC, from to . As of , FDA records show no recalls naming K832916.

Clearance record

Decision date
Received
(77 days to decision)
Product code
LLE Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease
Device class
Class III
Review panel
Unknown
Applicant
Critikon Company, LLC 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LLE

Trailing 12 months

FDA records hold no clearances under product code LLE in the trailing twelve months.

FDA records show no clearances under product code LLE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LLE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260