KDK — Container, Transport, Kidney Class II

FDA Device Classification

FDA product code KDK covers "Container, Transport, Kidney", a Class II medical device regulated under 21 CFR 876.5880. Submissions are reviewed by the Gastroenterology, Urology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
KDK
Device Class
Class II
Regulation Number
876.5880
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K053169waters instrumentsRM3 RENAL PRESERVATION SYSTEMJanuary 17, 2006
K911577martin mclane medicalHYPOTRANS MODEL 750July 8, 1992
K801899keithley developmentKEITHLEY LYMPHOCYTE DEPLETION CARTSeptember 26, 1980