BSS

13 FDA 510(k) clearances · Product code

143 daysmedian time to decision

567 days90th percentile

13clearances measured

FDA profile

Official device name: Tube, Nasogastric
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5980
Medical specialty: Gastroenterology, Urology
Flags: Third-party review eligible
Adverse events (MAUDE): 2003: 4 · 2004: 3 · 2005: 2 · 2019: 14 · 2022: 22 · 2023: 27
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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Record	Firm	Date
TurboSEAL Nasogastric Aspiration Tube (K142483)	Turboseal, L.P.	2014-12-19
ENTERAL FEEDING TUBE (K051480)	Biosearch Medical Products, Inc.	2005-10-12
MOSS TUBES, INC. NASAL TUBE - MARK IV (K984629)	Moss Tubes, Inc.	1999-03-02
ASPISAFE GASTRIC TUBE (K961711)	B.Braun Medical, Inc.	1997-06-11
GASTRIC, CATHETER, IRRIGATION & ASPIRATION (K933596)	Polamedco, Inc.	1995-02-13
RADIUS ENTERAL FEEDING TUBE (K930510)	Radius Intl., Inc.	1995-02-01
AN-10S ANDERSEN TUBE WITH STYLET (K935688)	H.W. Andersen Products, Inc.	1994-12-30
TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR (K934348)	Tri-Med Specialties, Inc.	1994-12-23
XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A (K905573)	Zeon Medical Corp.	1991-06-19
ARGYLE POLYURETHANE SALEM SUMP TUBE (K910479)	Sherwood Medical Co.	1991-04-19
WILTEK NASAL BILIARY DRAINAGE SET (K894870)	Wiltek Medical, Inc.	1989-12-21
TECNOL NASO-GASTRIC TUBE HOLDER (K891187)	Tecnol New Jersey Wound Care, Inc.	1989-05-30
FLEXIFLO ENTERAL PUMP SET (K791531)	Abbott Laboratories	1979-09-12

Track BSS automatically

Every clearance here is in the API, with alerts when new ones post.