FBS — Sound, Metal, Interconnected Class I

FDA Device Classification

FDA product code FBS covers "Sound, Metal, Interconnected", a Class I medical device regulated under 21 CFR 876.4590. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
FBS
Device Class
Class I
Regulation Number
876.4590
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K954972venture managementLYELL SOUNDJanuary 24, 1996