EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE - OLYMPUS TGF-UC180J
Device Description
An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. It is inserted into the body through the mouth during gastroduodenoscopy. Anatomical images are transmitted to the user through a fibreoptic bundle or a video system and the ultrasound probe. The probe may be built-in, or inserted through a dedicated lumen. This device is commonly used to examine structures of the stomach, duodenum, pancreas, and bile duct. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Ethylene Oxide
- High-level Disinfectant
Product Codes
Code: NWB
Device Name: Endoscope, Accessories, Narrow Band Spectrum
Device Class: 2
Physical State: The system consists of flexible and/or ridgid scope(s), light source(s), video processor and display
Definition: Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract.
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Enhances visualization of specific structures and reduces obscuring effects by using narrow bands of the visible spectrum for illumination. Narrow band illumination is accomplished through the modification of broadband light sources with optical filters or using light sources with inherently limited spectra such as lasers
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Limited to endoscopic systems for observation of the gastro-urological tract
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Code: FBN
Device Name: Choledochoscope And Accessories, Flexible/Rigid
Device Class: 2
Physical State: endoscope, accessories associated with choledochoscope
Definition: to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: instrument guided laparoscopically or through the esophagus into the biliary tree
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: bile ducts
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 04953170355493
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A