510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K010008Substantially Equivalent

Axxess Spinal Cord Stimulation Lead, Model 8000 Series, Including 80Xx, 81Xx, and 82Xx

Micronet Medical, Inc., White Bear Lake, MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010008 is the FDA 510(k) clearance record for AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX, a class II device, cleared for Micronet Medical, Inc. on under FDA product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)). FDA records list one 510(k) clearance for Micronet Medical, Inc. As of , FDA records show no recalls naming K010008.

Clearance record

Decision date
Received
(195 days to decision)
Product code
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Regulation
21 CFR 882.5880
Device class
Class II
Review panel
Neurology
Applicant
Micronet Medical, Inc. 1839 Buerkle Rd., White Bear Lake, MN
510(k) summary
Summary
Third party review
No

Clearances, product code GZB

Trailing 12 months

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

FDA records show no clearances under product code GZB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GZB, 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