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510(k) K983665

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

K983665 is an FDA 510(k) premarket notification submitted by Dentsleeve Pty., Ltd. for the device "MANOMETRIC ASSEMBLIES". The FDA issued a decision of Substantially Equivalent on May 17, 1999. The device falls under product code KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube), a Class II device regulated under 21 CFR 876.1725. Dentsleeve Pty., Ltd. has at least 2 other 510(k) clearances on record.

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)

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