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USW Needleknife Papillotome

FDA 510(k)

Class II (US FDA 510(k))

510(k) K040981

by Wilson-Cook Medical, Inc.

Identifiers

510(k) Number
K040981 FDA 510(k)
FDA Product Code
KNS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.4300 FDA 510(k)
Regulation Number
876.4300 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The USW Needleknife Papillotome is classified as an Unit, Electrosurgical, Endoscopic (With or Without Accessories) device. It is designed as a surgical instrument used in endoscopic procedures to access and incise tissue, specifically within the biliary system. The device incorporates a 23 gauge needle and a papillotome mechanism, enabling precise cutting and dilation of strictures or obstructions in the common bile duct when conventional cannulation techniques are ineffective.

This device is supplied sterile and intended for single-use applications. It is compatible with the accessory channel of standard endoscopes and is intended for use in gastroenterology and urology procedures. The USW Needleknife Papillotome has received FDA 510(k) clearance under the Special 510(k) program, with a classification of Class II. It is regulated under 21 CFR 876.4300 and is distributed by Wilson-Cook Medical, Inc., Winston-Salem, NC.

Frequently asked questions

What is the USW Needleknife Papillotome used for?

The USW Needleknife Papillotome is designed for endoscopic procedures to access and incise tissue within the biliary system. It is specifically intended for cutting and dilating strictures or obstructions in the common bile duct when standard cannulation techniques are ineffective. The device’s 23-gauge needle and papillotome mechanism enable targeted intervention in complex cases.

How is the USW Needleknife Papillotome supplied and prepared for use?

The USW Needleknife Papillotome is supplied sterile, ensuring immediate readiness for single-use applications. It does not require additional sterilization or preparation beyond unpacking, making it convenient for procedural use. The device is compatible with the accessory channel of standard endoscopes, ensuring seamless integration into existing workflows.

Is the USW Needleknife Papillotome intended for single-use or reuse?

This device is explicitly designed for single-use only. Its sterile packaging and intended use in endoscopic procedures align with medical best practices to prevent cross-contamination and ensure patient safety. Reuse is not recommended or supported by the manufacturer.

What medical specialties commonly use the USW Needleknife Papillotome?

The USW Needleknife Papillotome is primarily utilized in gastroenterology and urology procedures. Its specialized design addresses biliary access challenges, making it a valuable tool for clinicians managing complex cases involving strictures or obstructions in the bile duct.

How should the USW Needleknife Papillotome be stored before use?

The device should be stored in its original, unopened sterile packaging until ready for use. It must be kept in a clean, dry environment, protected from moisture, extreme temperatures, and direct sunlight. Proper storage ensures sterility and functionality until the intended single-use procedure.

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: USW NEEDLEKNIFE PAPILLOTOME (K040981) — FDA 510(k) | Innolitics, Zimmon® Needle Knife Papillotome - Cook Medical, WILSON-COOK NEEDLE KNIFE PAPILLOTOME by WILSON-COOK MEDICAL, INC. | FDA ..., Zimmon Needle Knife Papillotome by Wilson-Cook Medical, Inc. / Cook ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wilson-Cook Medical, Inc.

Sources (1)

  • FDA 510(k) K040981 24 fields · synced Oct 1, 2026