FWL — Camera, Cine, Endoscopic, Without Audio Class I

FDA Device Classification

FDA product code FWL covers "Camera, Cine, Endoscopic, Without Audio", a Class I medical device regulated under 21 CFR 878.4160. 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
FWL
Device Class
Class I
Regulation Number
878.4160
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K951519wells johnsonWECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTJune 14, 1995
K883760storz instrumentSTORZ MODEL 62 ENT CAMERA SYSTEMSeptember 28, 1988