GDN — Knife, Amputation Class I

FDA Device Classification

FDA product code GDN covers "Knife, Amputation", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification details

Product Code
GDN
Device Class
Class I
Regulation Number
878.4800
Submission Type
510(k) Exempt
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) clearances

K-NumberApplicantDevice NameDate
K851752Artiberia9-190,9-200,9-210,9-220 AMPUTATION KNIVES, VARIOUSJun 20, 1985

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.