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510(k) K954798

7100 SWALLOWING WORKSTATION by Kay Elemetrics Corp. — Product Code KLA

K954798 is an FDA 510(k) premarket notification submitted by Kay Elemetrics Corp. for the device "7100 SWALLOWING WORKSTATION". The FDA issued a decision of Substantially Equivalent on June 4, 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. Kay Elemetrics Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1996
Date Received
October 18, 1995
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 Kay Elemetrics Corp.

  • K991738 — DIGITAL VIDEO RECORDING SYSTEM (August 13, 1999)
  • K990240 — ELECTROGLOTTOGRAPH (March 11, 1999)
  • K921285 — 9105 RIGID TELESCOPIC ENDOSCOPE (May 28, 1992)
  • K921184 — RLS 9100 RHINO-LARYNGEAL STROBOSCOPE (May 28, 1992)

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