Home / 510(k) Clearances / K926073

510(k) K926073

ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE by Surgimark, Inc. — Product Code FEG

K926073 is an FDA 510(k) premarket notification submitted by Surgimark, Inc. for the device "ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE". The FDA issued a decision of Substantially Equivalent on May 15, 1995. 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. Surgimark, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1995
Date Received
December 1, 1992
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 by Surgimark, Inc.

  • K932689 — LAPRO-LOADER(TM) (April 11, 1994)
  • K871950 — VIA-GUARD (July 23, 1987)

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)
  • 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)
  • K880850 — KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE (May 26, 1988)

FDA data resources