Home / 510(k) Clearances / K961070

510(k) K961070

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

K961070 is an FDA 510(k) premarket notification submitted by Synectics Medical, Inc. for the device "ESOPHAGEAL MANOMETRY ANALYSIS MODULE". The FDA issued a decision of Substantially Equivalent on June 11, 1996. The device falls under product code KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube), a Class II device regulated under 21 CFR 876.1725. Synectics Medical, Inc. has at least 4 other 510(k) clearances on record.

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)

FDA data resources