Choledochoscope System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231497 FDA 510(k)
- FDA Product Code
- FBN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Choledochoscope System is a flexible/rigid endoscope designed for visual inspection of the biliary tree, including the common bile duct, cystic duct, and intrahepatic ducts. It enables direct visualization and diagnostic assessment of bile duct obstructions, strictures, or abnormalities during endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC).
This system is supplied as a reusable medical device, intended for use in clinical settings such as endoscopy suites or operating rooms. It is classified under FDA regulation 876.1500 and includes multiple accessory components, each identified by unique FEI numbers. The device requires proper sterilization and maintenance per manufacturer guidelines to ensure safety and functionality. Authorizations include FDA 510K clearance and MDR compliance.
Frequently asked questions
What clinical procedures is the Choledochoscope System primarily used for during visualization of the biliary tree?
The Choledochoscope System is designed for direct visualization of the biliary tree during endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC). It enables diagnostic assessment of obstructions, strictures, or abnormalities in the common bile duct, cystic duct, and intrahepatic ducts, supporting real-time evaluation during these procedures.
Is the Choledochoscope System reusable, and if so, what maintenance or sterilization requirements apply?
Yes, the Choledochoscope System is a reusable medical device, intended for use in clinical settings like endoscopy suites or operating rooms. Proper sterilization and maintenance per the manufacturer’s guidelines are required to ensure safety and functionality. The system includes multiple accessory components, each with unique FEI numbers, which must also be handled according to established protocols.
How many accessory components are included in the Choledochoscope System, and are they all reusable?
The Choledochoscope System includes multiple accessory components, each identified by unique FEI numbers (e.g., 3003782610, 3038296436, etc.). While the system itself is reusable, the accessories are also part of the reusable design, meaning they must be sterilized and maintained following manufacturer instructions for repeated clinical use.
What regulatory pathways has the Choledochoscope System undergone, and which committees were involved in its review?
The Choledochoscope System has received FDA 510K clearance and MDR compliance, indicating it was evaluated for substantial equivalence to existing devices. The review was conducted under the Gastroenterology and Urology (GU) advisory committee, with a decision date of March 6, 2024, confirming its classification under FDA regulation 876.1500 for flexible/rigid choledochoscopes.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K231497 | Class II | Active |
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Manufacturer
Sources (2)
- FDA 510(k) K231497 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026