Home / 510(k) Clearances / K961070

510(k) K961070

ESOPHAGEAL MANOMETRY ANALYSIS MODULE by Synectics Medical, Inc. — Product Code KLA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1996
Date Received
March 18, 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 Synectics Medical, Inc.

  • K963330 — URODYNAMIC ANALYSIS MODULE (April 3, 1997)
  • K951442 — FLOLAB (August 24, 1995)
  • K946322 — POLYGRAM SOFTWARE (July 7, 1995)
  • K942445 — SYNERGY II (November 22, 1994)

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)