DeviceClearance

Product code NBG— Gastroenterology, Urology

ENDOMARK STERILE INDIA INK

Classification name
Marker, Colon
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

Market context for product code NBG

FDA has cleared 2 devices under product code NBG between 2000 and 2005, filed by 2 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 NBG

Recent clearances under product code NBG

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