Neuro Urodynamic Suite, Model 9032E0101

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K992715 ↗

FDA Product Code

FEN

Device Class

Class II

Regulation

21 CFR Part 876.1620

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Bilitec 2000, Polygram '98 Ph Testing Application (Incl.bile), Optical Fiber Prober

  Class II

  FDA 510(k) K011471 Active Cleared 8 Nov 2002

• Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry Application, Polygraf Id

  Class II

  FDA 510(k) K011472 Active Cleared 10 Aug 2001

• Anorectal Manometry Suite, Model 9032S0201

  Class II

  FDA 510(k) K991389 Active Cleared 15 Jul 1999

• Disposable Hypodermic Needle Electrode, Model 9013S0421, 9013S0431, 9013S0441, 9013S0451, 9013S0461, 1013S0421, 103S0431

  Class II

  FDA 510(k) K002992 Active Cleared 15 Aug 2001

• Polygram 98 Anorectal Function Testing Application, Model 9043S0111

  Class II

  FDA 510(k) K000386 Active Cleared 5 May 2000

• Disposable Monopolar Needle Electrode, Dmf 25; Dmn 25; Dmf 37; Dmn 37; Dmn 50; Dmn 75

  Class II

  FDA 510(k) K990375 Active Cleared 9 Mar 1999

See all devices from Medtronic Functional Diagnostics A/S →