Endoscopic Cholangiogram Kit
Gastroenterology, Urology · 21 CFR 876.1500
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
23 firms currently registered for this product code
Boston Scientific Corporation
Coventry, RI, US
Avid Medical, Inc. A Medical Action Ind. Company 305
TOANO, VA, US
Teleflex Medical Llc
Morrisville, NC, US
Medical Action Industries, Inc. 306
ARDEN, NC, US
Cardinal Health 200, Llc
El Paso, TX, US
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center
QUINCY, MA, US
Honduras Kitting, S.a.
Villanueva Cortes, HN
Cook Incorporated
Bloomington, IN, US
Sterigenics U.s., Llc
Ontario, CA, US
Isomedix Operations Inc
El Paso, TX, US
Cardinal Health 200, Llc
Waukegan, IL, US
Boston Scientific Limited
GALWAY, IE
Integra Lifesciences Corporation
Princeton, NJ, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Sterigenics Us Llc
Grand Prairie, TX, US
Beilun Plastech Inc
Ningbo Zhejiang, CN
Isomedix Operations Inc
EL PASO, TX, US
Sterigenics U.s., Llc
Charlotte, NC, US
Inventex Medical
Niles, IL, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Boston Scientific Corporation
Marlborough, MA, US
Synergy Health Ast, Srl
Alajuela, CR
Teleflex Medical De Tecate, S. De R.l De C.v.
TECATE Baja California, MX
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.