510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925106Substantially Equivalent

Implantable Pulse Generators

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

K925106 is the FDA 510(k) clearance record for IMPLANTABLE PULSE GENERATORS, a class II device, cleared for Medtronic Vascular on under FDA product code DYX (Lock, Wire, And Ligature, Intraoral). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K925106.

Clearance record

Decision date
Received
(362 days to decision)
Product code
DYX Lock, Wire, And Ligature, Intraoral
Regulation
21 CFR 872.4600
Device class
Class II
Review panel
Dental
Applicant
Medtronic Vascular 7000 Central Ave., NE, Minneapolis MN
510(k) summary
Summary
Third party review
No

Clearances, product code DYX

Trailing 12 months

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

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