FEC — Obturator, For Endoscope Class II

FDA Device Classification

FDA product code FEC covers "Obturator, For Endoscope", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FEC
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K001328novasys medicalINTRODUCER SHEATHJuly 17, 2000
K760172v. mueller o.v. baxter healthcareOBTURATOR, VISUALDecember 2, 1976
K760183v. mueller o.v. baxter healthcareOBTURATOR, DEFLECTINGDecember 2, 1976