510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K950425Substantially Equivalent

Tecothane 55D

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

K950425 is the FDA 510(k) clearance record for TECOTHANE 55D, a class II device, cleared for Medtronic Vascular on under FDA product code GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief)). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K950425.

Clearance record

Decision date
Received
(76 days to decision)
Product code
GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Regulation
21 CFR 882.5870
Device class
Class II
Review panel
Neurology
Applicant
Medtronic Vascular 800 53rd Ave., NE, Minneapolis MN
510(k) summary
Summary
Third party review
No

Clearances, product code GZF

Trailing 12 months
1 clearance under product code GZF in the twelve months to November 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GZF, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260
November 20260