Home / 510(k) Clearances / K921682

510(k) K921682

ZINETICS AMC by Zinetics Medical, Inc. — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1994
Date Received
April 8, 1992
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 Zinetics Medical, Inc.

  • K910694 — ZINETICS INTERNAL REFERENCE PROBE (May 17, 1991)
  • K884527 — ZINETICS(R) EMC (February 28, 1989)
  • K883319 — HILL NASOGASTRIC TUBE (December 5, 1988)

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)