PUP — Endoscope Maintenance System Class II

FDA Device Classification

FDA product code PUP covers "Endoscope Maintenance System", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

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

Definition

To assist in disinfecting, rinsing and storing endoscopes or similar elongated instruments.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K860246buckman coENDOSCOPE ACCESSORIES, CLEANING, FOR ENDOSCOPEApril 2, 1986