510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K810182Substantially Equivalent

Programmable Spinal Coral Stim. System

Electronic Diagnostics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810182 is the FDA 510(k) clearance record for PROGRAMMABLE SPINAL CORAL STIM. SYSTEM, a class II device, cleared for Electronic Diagnostics, Inc. on under FDA product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)). FDA records list one 510(k) clearance for Electronic Diagnostics, Inc. As of , FDA records show no recalls naming K810182.

Clearance record

Decision date
Received
(71 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
Electronic Diagnostics, Inc. 803 N. Front St. Suite 3, Mchenry IL
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