- Physicians Office Resource

OES CHOLEDOCHOFIBERSCOPE - OLYMPUS CHF TYPE CB30L

Device Description

An endoscope with a flexible inserted portion intended for the visual examination and treatment of the choledoc, better known as the common bile duct (CBD). It is inserted into the body through an artificial orifice created by an incision in the abdomen (laparoscopic technique), or introduced via a flexible duodenoscope during choledochoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine structures of the CBD and for the removal of stones. 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

Ethylene Oxide
High-level Disinfectant

Product Codes

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 Identifiers

Device Id: 04953170058950

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

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