Home / 510(k) Clearances / K902421

510(k) K902421

STOMACH, GASTRO-ENTEROSTOMY by Gainor Medical Europe, Ltd. — Product Code KDH

K902421 is an FDA 510(k) premarket notification submitted by Gainor Medical Europe, Ltd. for the device "STOMACH, GASTRO-ENTEROSTOMY". The FDA issued a decision of Substantially Equivalent on November 20, 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. Gainor Medical Europe, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1990
Date Received
May 31, 1990
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 by Gainor Medical Europe, Ltd.

  • K926448 — I.V. ADMINISTRATION SET (May 2, 1994)
  • K931828 — CARELET SAFETY LANCET (October 15, 1993)
  • K931827 — CLEANLET, CLEANLET XL & KIDS (September 13, 1993)
  • K922441 — SURESEAL BANDAGE (August 10, 1993)
  • K913333 — I.V. PRIMING SET (October 23, 1991)
  • K902422 — NEEDLE, ASPIRATION & INJECTION, DISPOSABLE (June 6, 1991)
  • K902420 — CATHETER, NASAL, OXYGEN (April 17, 1991)
  • K902564 — NEEDLE, DIALYSIS (March 1, 1991)
  • K902426 — HEMODIALYSIS SYSTEM AND ACCESSORY (November 20, 1990)
  • K902416 — SURELITE AND SURELITE XL BLOOD LANCET (August 1, 1990)

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)
  • K920527 — TRI-MED QUICK-STEP GASTRIC LAVAGE KIT (September 4, 1992)
  • K920619 — TRI-MED GASTRIC LAVAGE SYSTEM (September 4, 1992)
  • K914908 — QUICVAGE PLUS (April 13, 1992)
  • K914907 — QUICVAGE (January 24, 1992)

FDA data resources