GDR — Saw, Manual And Accessories Class I

FDA Device Classification

FDA product code GDR covers "Saw, Manual And Accessories", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
GDR
Device Class
Class I
Regulation Number
878.4800
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K874961solwayBONE CUTTING INSTRUMENTS & ACCESSORIESDecember 30, 1987
K851787artiberia27-100 TO 29-130 VARIOUS BONE SAWS-CHARRIERE, SATTJune 20, 1985