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510(k) K981286

SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS by Armm, Inc. — Product Code KDH

K981286 is an FDA 510(k) premarket notification submitted by Armm, Inc. for the device "SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS". The FDA issued a decision of Substantially Equivalent on June 19, 1998. The device falls under product code KDH (Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration), a Class II device regulated under 21 CFR 876.5980. Armm, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1998
Date Received
April 8, 1998
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 Armm, Inc.

  • K923201 — ENDOSI SUCTION IRRIGATOR (September 23, 1993)
  • K922245 — SUPER-FLOW TUBING (September 3, 1993)
  • K931607 — MEDDRAINS (August 6, 1993)

Other clearances for product code KDH

  • K983624 — GILTECH PLUS CONNECTING TUBE SET (March 18, 1999)
  • 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)
  • K911788 — ECONOVAGE R (July 26, 1991)

FDA data resources