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510(k) K896573

EASI-LAV ADULT GASTRIC LAVAGE KIT by Clairson Industries, LLC — Product Code KDH

K896573 is an FDA 510(k) premarket notification submitted by Clairson Industries, LLC for the device "EASI-LAV ADULT GASTRIC LAVAGE KIT". The FDA issued a decision of Substantially Equivalent on January 29, 1990. The device falls under product code KDH (Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration), a Class II device regulated under 21 CFR 876.5980.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1990
Date Received
November 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances for product code KDH

  • K983624 — GILTECH PLUS CONNECTING TUBE SET (March 18, 1999)
  • K981286 — SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS (June 19, 1998)
  • K971259 — COMBIPORT FLUID LAVAGE DEVICE (October 27, 1997)
  • K962850 — TUM-E-VAC (February 21, 1997)
  • K951533 — EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT (July 5, 1995)
  • K923497 — FLUSHING IRRIGATION SET (March 21, 1994)
  • K920619 — TRI-MED GASTRIC LAVAGE SYSTEM (September 4, 1992)
  • K920527 — TRI-MED QUICK-STEP GASTRIC LAVAGE KIT (September 4, 1992)
  • K914908 — QUICVAGE PLUS (April 13, 1992)
  • K914907 — QUICVAGE (January 24, 1992)

FDA data resources