Product code FAL— Gastroenterology, Urology

ENDOSCOPE, UROLOGICAL, FEMALE

Classification name
Panendoscope (Urethroscope)
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

Market context for product code FAL

FDA has cleared 1 device under product code FAL, all in 1977, filed by 1 applicant company. 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.

Top applicants under product code FAL

Recent clearances under product code FAL

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