510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K041244Substantially Equivalent

Polygram Net Biofeedback Application

Medtronic, Inc., Shoreview MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041244 is the FDA 510(k) clearance record for POLYGRAM NET BIOFEEDBACK APPLICATION, a class II device, cleared for Medtronic Vascular on under FDA product code HCC (Device, Biofeedback). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K041244.

Clearance record

Decision date
Received
(93 days to decision)
Product code
HCC Device, Biofeedback
Regulation
21 CFR 882.5050
Device class
Class II
Review panel
Neurology
Applicant
Medtronic Vascular 4000 Lexington Ave. N., Shoreview MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HCC

Trailing 12 months

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

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