510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991389Substantially Equivalent

Anorectal Manometry Suite, Model 9032S0201

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

K991389 is the FDA 510(k) clearance record for ANORECTAL MANOMETRY SUITE, MODEL 9032S0201, a class II device, cleared for Medtronic Functional Diagnostics A/S on under FDA product code FFX (System, Gastrointestinal Motility (Electrical)). FDA records list 11 510(k) clearances for Medtronic Functional Diagnostics A/S, from to . As of , FDA records show no recalls naming K991389.

Clearance record

Decision date
Received
(85 days to decision)
Product code
FFX System, Gastrointestinal Motility (Electrical)
Regulation
21 CFR 876.1725
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medtronic Functional Diagnostics A/S Tonsbakken 16-18, Copenhagen, DK
510(k) summary
Summary
Third party review
No

Clearances, product code FFX

Trailing 12 months
1 clearance under product code FFX 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 FFX, 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 20260
October 20260