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510(k) K970595

CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP by Circon Video — Product Code FEN

K970595 is an FDA 510(k) premarket notification submitted by Circon Video for the device "CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP". The FDA issued a decision of Substantially Equivalent on October 24, 1997. The device falls under product code FEN (Device, Cystometric, Hydraulic), a Class II device regulated under 21 CFR 876.1620. Circon Video has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1997
Date Received
February 18, 1997
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 by Circon Video

  • K012758 — URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE (April 9, 2002)
  • K011876 — DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 (January 8, 2002)
  • K011849 — MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETER (December 10, 2001)
  • K012929 — FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 (November 19, 2001)
  • K012951 — APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE (November 9, 2001)
  • K012925 — DUR-8, MODELS DUR-8 (November 7, 2001)
  • K012265 — METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 (October 17, 2001)
  • K012153 — LOWSLEY SUPRAPUBIC TRACTOR (September 19, 2001)
  • K011848 — CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE (September 11, 2001)
  • K914883 — CIRCON ACMI GEN SURG INSTRU FOR MINI INVASIVE SURG (January 15, 1993)

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)
  • K971911 — LUMAX CYSTOMETRY ADMINISTRATION TUBE SET (June 3, 1997)
  • K964522 — ELLIPSE 4 (March 21, 1997)
  • K960503 — DANTEC DUET (September 16, 1996)
  • K953734 — LUMAX(MODIFICATION) (January 18, 1996)

FDA data resources