FDA 510(k) Applications for Medical Device Product Code: ODB (Endoscopic Contamination Prevention Sheath)

FDA 510(k) Applications for Medical Device Product Code "ODB"
(Endoscopic Contamination Prevention Sheath)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K183171	GI Scientific LLC	ScopeSeal Duodenoscope Protective Device	10/08/2019
K153698	LumenR, LLC	LumenR Tissue Retractor System	04/19/2016
K080550	MINOS MEDICAL	MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22	06/10/2008
K060475	OLYMPUS MEDICAL SYSTEMS CORPORATION	EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8	03/17/2006