Home / 510(k) Clearances / K964522

510(k) K964522

ELLIPSE 4 by Andromeda Medizinische Systeme GmbH — Product Code FEN

K964522 is an FDA 510(k) premarket notification submitted by Andromeda Medizinische Systeme GmbH for the device "ELLIPSE 4". The FDA issued a decision of Substantially Equivalent on March 21, 1997. The device falls under product code FEN (Device, Cystometric, Hydraulic), a Class II device regulated under 21 CFR 876.1620.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1997
Date Received
November 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Cystometric, Hydraulic
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

Other clearances for product code FEN

  • K212830 — CT3000Pro (December 21, 2021)
  • K082701 — URONIRS, MODEL 2000 (December 18, 2008)
  • K073552 — LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY (March 5, 2008)
  • K001386 — ACCUSET SENSOR, MODEL 2000 (July 17, 2000)
  • K992715 — NEURO URODYNAMIC SUITE, MODEL 9032E0101 (February 28, 2000)
  • K983325 — IN-PROBE II URODYNAMIC SYSTEM (November 24, 1998)
  • K970595 — CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP (October 24, 1997)
  • K971911 — LUMAX CYSTOMETRY ADMINISTRATION TUBE SET (June 3, 1997)
  • K960503 — DANTEC DUET (September 16, 1996)
  • K953734 — LUMAX(MODIFICATION) (January 18, 1996)

FDA data resources