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510(k) K884527

ZINETICS(R) EMC by Zinetics Medical, Inc. — Product Code KLA

K884527 is an FDA 510(k) premarket notification submitted by Zinetics Medical, Inc. for the device "ZINETICS(R) EMC". The FDA issued a decision of Substantially Equivalent on February 28, 1989. The device falls under product code KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube), a Class II device regulated under 21 CFR 876.1725. Zinetics Medical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1989
Date Received
October 27, 1988
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 Zinetics Medical, Inc.

  • K921682 — ZINETICS AMC (December 29, 1994)
  • K910694 — ZINETICS INTERNAL REFERENCE PROBE (May 17, 1991)
  • K883319 — HILL NASOGASTRIC TUBE (December 5, 1988)

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