Home / 510(k) Clearances / K190208

510(k) K190208

Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe by Diversatek Healthcare — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2019
Date Received
February 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Gastrointestinal Motility (Electrical)
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type

Other clearances by Diversatek Healthcare

  • K230056 — MiVu™ Esophageal Endo Cap (April 25, 2023)
  • K222734 — Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing (November 8, 2022)
  • DEN180067 — Mucosal Integrity Conductivity (MI) Test System (December 23, 2019)

Other clearances for product code FFX

  • K252605 — mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) (December 5, 2025)
  • K240007 — Solar Compact (G4-1) (May 6, 2024)
  • K231861 — EndoflipTM 300 System (July 21, 2023)
  • K223705 — EndoflipTM 300 (April 14, 2023)
  • K222000 — Transit-Pellets (January 18, 2023)
  • K201106 — IntraMarX 3D Radiopaque Marker (May 21, 2020)
  • K191087 — IntraMarX Radiopaque Markers (December 18, 2019)
  • K181760 — Transit-Pellets (August 8, 2019)
  • K183072 — EndoFLIP System (February 15, 2019)
  • K181750 — SITZMARKS (November 15, 2018)