FZO — Chisel, Surgical, Manual Class I

FDA Device Classification

FDA product code FZO covers "Chisel, Surgical, Manual", 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
FZO
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
K851788Artiberia29-140 TO 29-196 VARIOUS BONE CHISELS (OSTEOTOMES,Jun 20, 1985
K834198Imm EnterprisesJAKOBI SURG. INSTRUMENTS #12 40/41Jan 27, 1984

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