DeviceClearance

Product code FBO— Gastroenterology, Urology

ANCHORAGE SCOPE, MODEL 000003

Classification name
Cystourethroscope
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
19
First cleared
Most recent

Market context for product code FBO

FDA has cleared 19 devices under product code FBO between 1985 and 2025, filed by 13 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 FBO

Recent clearances under product code FBO

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