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ODB — Endoscopic Contamination Prevention Sheath Class II

FDA Device Classification

Classification Details

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

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K183171gi scientificScopeSeal Duodenoscope Protective DeviceOctober 8, 2019
K153698lumenrLumenR Tissue Retractor SystemApril 19, 2016
K080550minos medicalMEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22June 10, 2008
K060475olympus medical systems corporationEVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8March 17, 2006
K943697karl storz endoskopTROCARS,CANNULAE,SHEATHS,OBTURATORSSeptember 14, 1994