510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K903434Substantially Equivalent

Select Neuromuscular Stimulators

Medtronic, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903434 is the FDA 510(k) clearance record for SELECT NEUROMUSCULAR STIMULATORS, a class II device, cleared for Medtronic Vascular on under FDA product code GZI (Stimulator, Neuromuscular, External Functional). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K903434.

Clearance record

Decision date
Received
(374 days to decision)
Product code
GZI Stimulator, Neuromuscular, External Functional
Regulation
21 CFR 882.5810
Device class
Class II
Review panel
Neurology
Applicant
Medtronic Vascular 7000 Central Ave., NE, Minneapolis MN
Third party review
No

Clearances, product code GZI

Trailing 12 months

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

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