Gastro-urology Biopsy Kit
Gastroenterology, Urology · 21 CFR 876.1075
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
1 recall events for this product code
Registered firms
9 firms currently registered for this product code
Sterigenics U.s., Llc
Charlotte, NC, US
Busse Hospital Disposables
HAUPPAUGE, NY, US
Sterigenics Us Llc
Grand Prairie, TX, US
Isomedix Operations Inc
EL PASO, TX, US
Isomedix Operations Inc
El Paso, TX, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Cardinal Health 200, Llc
El Paso, TX, US
United States Endoscopy Group, Inc.
Mentor, OH, US
Cardinal Health 200, Llc
Waukegan, IL, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.