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510(k) K983665

MANOMETRIC ASSEMBLIES by Dentsleeve Pty., Ltd. — Product Code KLA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1999
Date Received
October 19, 1998
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 Dentsleeve Pty., Ltd.

  • K013154 — MARK II/MARK III MANOMETRIC PERFUSION PUMP (October 19, 2001)
  • K980946 — MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP (June 8, 1998)

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  • 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)