← Back to catalogue

Dragonfly™ Pancreaticobiliary Scope +2 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K233752

by CenterPoint Systems LLC

Identifiers

510(k) Number
K233752 FDA 510(k)
FDA Product Code
FBN FDA 510(k)
Models / Variants
Dragonfly™ Pancreaticobiliary Scope FDA 510(k)
Dragonfly™ Digital Controller FDA 510(k)
Dragonfly™ Instrument Channel Caps 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 Dragonfly Pancreaticobiliary Scope is a flexible choledochoscope designed for direct visualization and therapeutic intervention within the pancreaticobiliary system. It combines advanced imaging with a larger working channel to facilitate diagnostic and therapeutic procedures, including endoscopic retrograde cholangiopancreatography (ERCP). The system includes a digital controller for precise scope control and instrument channel caps to maintain sterility and prevent biomaterial leakage during use.

This device is supplied as a single-use system, intended for use in gastrointestinal endoscopic procedures. It is regulated under 21 CFR 876.1500 and has received FDA 510(k) clearance (K233752) as substantially equivalent to predicate devices. The scope and accessories are designed for compatibility within MRI-safe environments, though specific MRI safety labeling should be verified per procedure requirements. Storage and handling follow standard single-use medical device protocols to ensure sterility and functionality.

Frequently asked questions

What is the Dragonfly Pancreaticobiliary Scope designed for?

The Dragonfly Pancreaticobiliary Scope is a flexible choledochoscope specifically designed for direct visualization and therapeutic interventions within the pancreaticobiliary system. It is particularly useful for procedures like endoscopic retrograde cholangiopancreatography (ERCP), enabling both diagnostic and treatment applications in the biliary and pancreatic ducts.

How is the Dragonfly system supplied, and what does this mean for sterility?

The Dragonfly system is supplied as a single-use device, meaning each scope, digital controller, and instrument channel cap is intended for one procedure only. This design ensures sterility is maintained throughout use, eliminating the need for reprocessing and reducing the risk of cross-contamination between patients.

Can the Dragonfly Pancreaticobiliary Scope be used in MRI environments?

The Dragonfly Pancreaticobiliary Scope and its accessories are designed to be compatible with MRI-safe environments. However, it is important to verify specific MRI safety labeling and guidelines for each procedure to ensure proper use and patient safety.

What regulatory approval does the Dragonfly system hold?

The Dragonfly Pancreaticobiliary Scope, Digital Controller, and Instrument Channel Caps have received FDA 510(k) clearance (K233752) as substantially equivalent to predicate devices. This clearance confirms the device meets regulatory standards for safety and effectiveness in its intended use.

How should the Dragonfly system be stored to maintain functionality?

The Dragonfly system should be stored according to standard single-use medical device protocols to preserve sterility and functionality. This includes keeping the device in its original, unopened packaging in a clean, dry environment, away from direct sunlight or extreme temperatures, until immediate use.

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. Sources consulted: Dragonfly™* pancreaticobiliary system - Medtronic, Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller ..., PDF Pancreaticobiliary endoscopy, reimagined. - Medtronic

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
CenterPoint Systems LLC
FDA Applicant
CenterPoint Systems, LLC

Sources (1)

  • FDA 510(k) K233752 24 fields · synced Oct 1, 2026