Product code ODB— Gastroenterology, Urology

EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8

Classification name: Endoscopic Contamination Prevention Sheath
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Total cleared: 5
First cleared: 1994-09-14
Most recent: 2019-10-08

FDA classification definition

“To protect an endoscope from contamination by providing a barrier between the body and the endoscope.”
— U.S. Food and Drug Administration, device classification record for product code ODB under 21 CFR 876.1500, via openFDA

Market context for product code ODB

FDA has cleared 5 devices under product code ODB between 1994 and 2019, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20191 clearance
20161 clearance
20081 clearance
20061 clearance
19941 clearance

Top applicants under product code ODB

Olympus Medical Systems Corporation1 clearance
Minos Medical1 clearance
Lumenr, LLC1 clearance
Karl Storz Endoskop GmbH1 clearance
Gi Scientific, LLC1 clearance

Recent clearances under product code ODB

Data sourced from openFDA. This site is unofficial and independent of the FDA.