EXN — Support, Hernia Class I

FDA Device Classification

FDA product code EXN covers "Support, Hernia", a Class I medical device regulated under 21 CFR 876.5970. 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
EXN
Device Class
Class I
Regulation Number
876.5970
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K901922safteSAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536October 26, 1990