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510(k) K964589

FLEXILOG 3000 by Oakfield Instruments, Ltd. — Product Code KLA

K964589 is an FDA 510(k) premarket notification submitted by Oakfield Instruments, Ltd. for the device "FLEXILOG 3000". The FDA issued a decision of Substantially Equivalent on March 4, 1997. The device falls under product code KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube), a Class II device regulated under 21 CFR 876.1725. Oakfield Instruments, Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1997
Date Received
November 15, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Esophageal Motility, Anorectal Motility, And Tube
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type

Other clearances by Oakfield Instruments, Ltd.

  • K964804 — FLEXILOG LS (August 6, 1997)
  • K961895 — FLEXILOG LS 13921 (November 4, 1996)
  • K945069 — FLEXILOG 2000 (June 13, 1995)
  • K920115 — MEDISCINT (March 30, 1992)
  • K902460 — CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) (August 28, 1990)
  • K896288 — FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM (May 4, 1990)
  • K894902 — SOURCERER (October 17, 1989)

Other clearances for product code KLA

  • K242666 — Fecobionics Anorectal System (February 12, 2025)
  • K242304 — RED (December 6, 2024)
  • K234107 — Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) (April 23, 2024)
  • K180135 — THD Anopress with THD SensyProbe (March 8, 2018)
  • K161785 — THD ANOPRESS (March 14, 2017)
  • K143031 — mcompass Biofeedback Anorectal Manometry System (July 7, 2015)
  • K120088 — MCOMPASS ANORECTAL MANOMETRY SYSTEM (March 29, 2012)
  • K062362 — SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CA (April 13, 2007)
  • K031617 — MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER (January 16, 2004)
  • K032138 — MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANOREC (October 9, 2003)

FDA data resources