NBG — Marker, Colon Class II

FDA Device Classification

FDA product code NBG covers "Marker, Colon", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
NBG
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K042901pmtENDOMARK STERILE INDIA INKMarch 16, 2005
K993951chek-med systemsSPOT ENDOSCOPIC MARKERFebruary 18, 2000