Product code BSS— Gastroenterology, Urology

FDA has cleared 13 devices under product code BSS between 1979 and 2014, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20141 clearance
• 20051 clearance
• 19991 clearance
• 19971 clearance
• 19952 clearances
• 19942 clearances
• 19912 clearances
• 19892 clearances
• 19791 clearance

• Zeon Medical Corp.1 clearance
• Wiltek Medical, Inc.1 clearance
• Turboseal, L.P.1 clearance
• Tri-Med Specialties, Inc.1 clearance
• Tecnol New Jersey Wound Care, Inc.1 clearance
• Sherwood Medical Co.1 clearance
• Radius Intl., Inc.1 clearance
• Polamedco, Inc.1 clearance
• Moss Tubes, Inc.1 clearance
• H.W. Andersen Products, Inc.1 clearance

• K142483 — TurboSEAL Nasogastric Aspiration TubeTurboseal, L.P.·2014-12-19
• K051480 — ENTERAL FEEDING TUBEBiosearch Medical Products, Inc.·2005-10-12
• K984629 — MOSS TUBES, INC. NASAL TUBE - MARK IVMoss Tubes, Inc.·1999-03-02
• K961711 — ASPISAFE GASTRIC TUBEB.Braun Medical, Inc.·1997-06-11
• K933596 — GASTRIC, CATHETER, IRRIGATION & ASPIRATIONPolamedco, Inc.·1995-02-13
• K930510 — RADIUS ENTERAL FEEDING TUBERadius Intl., Inc.·1995-02-01
• K935688 — AN-10S ANDERSEN TUBE WITH STYLETH.W. Andersen Products, Inc.·1994-12-30
• K934348 — TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FRTri-Med Specialties, Inc.·1994-12-23
• K905573 — XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE AZeon Medical Corp.·1991-06-19
• K910479 — ARGYLE POLYURETHANE SALEM SUMP TUBESherwood Medical Co.·1991-04-19
• K894870 — WILTEK NASAL BILIARY DRAINAGE SETWiltek Medical, Inc.·1989-12-21
• K891187 — TECNOL NASO-GASTRIC TUBE HOLDERTecnol New Jersey Wound Care, Inc.·1989-05-30
• K791531 — FLEXIFLO ENTERAL PUMP SETAbbott Laboratories·1979-09-12