510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K014269Substantially Equivalent

Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf Id, Model 9043G0102

Medtronic Functional Diagnostics A/S, Skovlunde, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K014269 is the FDA 510(k) clearance record for POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102, a class II device, cleared for Medtronic Functional Diagnostics A/S on under FDA product code MYE (System, Electrogastrography (Egg)). FDA records list 11 510(k) clearances for Medtronic Functional Diagnostics A/S, from to . As of , FDA records show no recalls naming K014269.

Clearance record

Decision date
Received
(329 days to decision)
Product code
MYE System, Electrogastrography (Egg)
Regulation
21 CFR 876.1735
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medtronic Functional Diagnostics A/S 16-18 Tonsbakken, Skovlunde, DK
510(k) summary
Summary
Third party review
No

Clearances, product code MYE

Trailing 12 months
2 clearances under product code MYE in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MYE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260