TurboSEAL Nasogastric Aspiration Tube

FDA 510(k) K142483 · Turboseal, L.P.

Substantially Equivalent

510(k) numberK142483

Submission

Device name
TurboSEAL Nasogastric Aspiration Tube
Applicant
Turboseal, L.P.
Tel Aviv, IL
Received
September 4, 2014
Decision date
December 19, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BSS – Tube, Nasogastric
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5980
Specialty
Gastroenterology, Urology

Other 510(k)s with product code BSS

510(k)DeviceApplicantDecision
K051480Enteral Feeding TubeBSS · Traditional Biosearch Medical Products, Inc.10/12/2005SE
K984629Moss Tubes, Inc. Nasal Tube - Mark IVBSS · Traditional Moss Tubes, Inc.03/02/1999SE
K961711Aspisafe Gastric TubeBSS · Traditional B.Braun Medical, Inc.06/11/1997SE
K933596Gastric, Catheter, Irrigation & AspirationBSS · Traditional Polamedco, Inc.02/13/1995SE
K930510Radius Enteral Feeding TubeBSS · Traditional Radius Intl., Inc.02/01/1995SE
K935688AN-10S Andersen Tube with StyletBSS · Traditional H.W. Andersen Products, Inc.12/30/1994SE
K934348Tri-Med Quick-Step Gastric Lavage Tube Sizes 18FR, 22FR, 32FRBSS · Traditional Tri-Med Specialties, Inc.12/23/1994SE
K905573Xemex Enteral Nutrition Catheter Nasogas. Type aBSS · Traditional Zeon Medical Corp.06/19/1991SE
K910479Argyle Polyurethane Salem Sump TubeBSS · Traditional Sherwood Medical Co.04/19/1991SE
K894870Wiltek Nasal Biliary Drainage SetBSS · Traditional Wiltek Medical, Inc.12/21/1989SE

Questions and answers

When was TurboSEAL Nasogastric Aspiration Tube cleared by the FDA?

TurboSEAL Nasogastric Aspiration Tube (K142483) received a 510(k) decision of Substantially Equivalent on December 19, 2014, 106 days after the submission was received.

What is the product code of K142483?

The FDA product code is BSS – Tube, Nasogastric, a Class II (moderate risk) device regulated under 21 CFR 876.5980.