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510(k) K880850

KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE by Kmb Medical Products Co. — Product Code FEG

K880850 is an FDA 510(k) premarket notification submitted by Kmb Medical Products Co. for the device "KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE". The FDA issued a decision of Substantially Equivalent on May 26, 1988. The device falls under product code FEG (Tube, Double Lumen For Intestinal Decompression And/Or Intubation), a Class II device regulated under 21 CFR 876.5980.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1988
Date Received
March 1, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances for product code FEG

  • K171619 — 14Fr Colon Decompression Set, Macon Colon Decompression Set (August 1, 2017)
  • K132314 — MEDLINE ANTI-REFLUX VALVE (September 18, 2013)
  • K053410 — GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR (January 6, 2006)
  • K040388 — NEXT GENERATION SALEM SUMP (May 17, 2004)
  • K971354 — KNOTT NG TUBE (November 19, 1997)
  • K960176 — DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER (July 24, 1996)
  • K926073 — ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE (May 15, 1995)
  • K935781 — ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY (January 27, 1995)
  • K921104 — LOPEZ VALVE WITH NG SUMP TUBE (October 26, 1992)
  • K900035 — WILSON-COOK COLON DECOMPRESSION SET (March 7, 1990)

FDA data resources