FDG — Retractor, Fiberoptic Class I

FDA Device Classification

FDA product code FDG covers "Retractor, Fiberoptic", a Class I medical device regulated under 21 CFR 876.4530. Submissions are reviewed by the Gastroenterology, Urology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FDG
Device Class
Class I
Regulation Number
876.4530
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K964561bioentericsENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020,February 11, 1997
K945421stephen chakoffCHAKOFF ENDOSCOPYDecember 23, 1994