FJZ — Declotting Tray, Kit (Including Contents) Class II

FDA Device Classification

FDA product code FJZ covers "Declotting Tray, Kit (Including Contents)", a Class II medical device regulated under 21 CFR 876.5820. 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
FJZ
Device Class
Class II
Regulation Number
876.5820
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K821666phoenix gloveSTERILE SURGICAL DRAPESJune 21, 1982
K821313megaplastSURGICAL UTILITY DRAPEJune 21, 1982
K760995dravon medicalDECOLLATING TRAYJanuary 6, 1977