Product code FJZ— Gastroenterology, Urology

DECOLLATING TRAY

Classification name
Declotting Tray, Kit (Including Contents)
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Total cleared
3
First cleared
Most recent

Market context for product code FJZ

FDA has cleared 3 devices under product code FJZ between 1977 and 1982, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code FJZ

Recent clearances under product code FJZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.