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510(k) K142483

TurboSEAL Nasogastric Aspiration Tube by Turboseal, L.P. — Product Code BSS

K142483 is an FDA 510(k) premarket notification submitted by Turboseal, L.P. for the device "TurboSEAL Nasogastric Aspiration Tube". The FDA issued a decision of Substantially Equivalent on December 19, 2014. The device falls under product code BSS (Tube, Nasogastric), a Class II device regulated under 21 CFR 876.5980.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2014
Date Received
September 4, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Nasogastric
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances for product code BSS

  • K051480 — ENTERAL FEEDING TUBE (October 12, 2005)
  • K984629 — MOSS TUBES, INC. NASAL TUBE - MARK IV (March 2, 1999)
  • K961711 — ASPISAFE GASTRIC TUBE (June 11, 1997)
  • K933596 — GASTRIC, CATHETER, IRRIGATION & ASPIRATION (February 13, 1995)
  • K930510 — RADIUS ENTERAL FEEDING TUBE (February 1, 1995)
  • K935688 — AN-10S ANDERSEN TUBE WITH STYLET (December 30, 1994)
  • K934348 — TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR (December 23, 1994)
  • K905573 — XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A (June 19, 1991)
  • K910479 — ARGYLE POLYURETHANE SALEM SUMP TUBE (April 19, 1991)
  • K894870 — WILTEK NASAL BILIARY DRAINAGE SET (December 21, 1989)

FDA data resources