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510(k) K000386

POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111 by Medtronic Functional Diagnostics A/S — Product Code FFX

K000386 is an FDA 510(k) premarket notification submitted by Medtronic Functional Diagnostics A/S for the device "POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111". The FDA issued a decision of Substantially Equivalent on May 5, 2000. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Medtronic Functional Diagnostics A/S has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2000
Date Received
February 7, 2000
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 Medtronic Functional Diagnostics A/S

  • K014269 — POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF (November 21, 2002)
  • K011471 — BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PRO (November 8, 2002)
  • K002992 — DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013 (August 15, 2001)
  • K011472 — POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOM (August 10, 2001)
  • K010130 — POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 (February 7, 2001)
  • K992715 — NEURO URODYNAMIC SUITE, MODEL 9032E0101 (February 28, 2000)
  • K992713 — POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G (November 10, 1999)
  • K991389 — ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 (July 15, 1999)
  • K990375 — DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; D (March 9, 1999)
  • K981733 — DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111 (February 4, 1999)

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)
  • K190208 — Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe (October 3, 2019)
  • K181760 — Transit-Pellets (August 8, 2019)
  • K183072 — EndoFLIP System (February 15, 2019)

FDA data resources