ODB

Endoscopic Contamination Prevention Sheath

Product code: ODB
Device name: Endoscopic Contamination Prevention Sheath
Device class: Class 2
21 CFR: 21 CFR 876.1500
Medical specialty: Gastroenterology, Urology
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 5 (all years; only the last 3 years are listed here)

FDA classification definition

To protect an endoscope from contamination by providing a barrier between the body and the endoscope.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: ODB

Classification and pathway per current FDA publications. Data from openFDA (CC0).