Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures
Orthopedic · 21 CFR 888.1100
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
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Registered firms
8 firms currently registered for this product code
Isomedix Operations Inc
El Paso, TX, US
Sterigenics U.s., Llc
Charlotte, NC, US
Cardinal Health 200, Llc
El Paso, TX, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Sterigenics Us Llc
Grand Prairie, TX, US
Cardinal Health 200, Llc
Waukegan, IL, US
Isomedix Operations Inc
EL PASO, TX, US
Orthopedic Sciences, Inc
Overland Park, KS, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.