FXG — Specula Accessories Class I

FDA Device Classification

FDA product code FXG covers "Specula Accessories", a Class I medical device regulated under 21 CFR 878.1800. 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
FXG
Device Class
Class I
Regulation Number
878.1800
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K891589semantodontics3MM DISPOSABLE SPECULAApril 18, 1989