DeviceClearance

Product code FAA— Unknown

COAXIAL BALLOON URETHRAL DILATOR

Classification name
Replacer, Urethral
Device class
Class 3
Advisory panel
Unknown
Total cleared
1
First cleared
Most recent

Market context for product code FAA

FDA has cleared 1 device under product code FAA, all in 1983, filed by 1 applicant company. No FDA device recalls reference this product code. Class III devices are high-risk and generally require premarket approval (PMA); 510(k) clearance under a Class III product code is limited to certain preamendments-type devices.

Top applicants under product code FAA

Recent clearances under product code FAA

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