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Papillotome

by United States Endoscopy Group, Inc. 510(k)

Active United States

510(k) K962346

Overview

The Papillotome is an Electrosurgical, Endoscopic Unit designed for cutting and excising tissue, particularly within the biliary or pancreatic ducts. It operates via electrosurgical energy to precisely incise strictures, stones, or other obstructions during endoscopic retrograde cholangiopancreatography (ERCP) or similar procedures.

This device is supplied as a reusable, non-sterile instrument intended for use in controlled clinical settings such as endoscopy suites. It requires sterilization between procedures and must be handled in accordance with electrosurgical safety protocols. The Papillotome is classified under FDA 510(k) clearance (K962346) and adheres to regulatory standards for endoscopic accessories in gastroenterology and urology.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK962346 Date8 Aug 1996ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KNS
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Papillotome primarily used for in clinical procedures?

    The Papillotome is designed for cutting and excising tissue during endoscopic procedures, specifically within the biliary or pancreatic ducts. It is most commonly used to precisely incise strictures, stones, or obstructions encountered during endoscopic retrograde cholangiopancreatography (ERCP) or similar interventions. Its electrosurgical function allows for controlled tissue removal in these delicate anatomical areas.

  • Is the Papillotome intended for single-use or reusable applications?

    The Papillotome is supplied as a reusable instrument and is not intended for single-use. It must be sterilized between procedures to maintain safety and sterility standards, adhering to electrosurgical safety protocols in controlled clinical settings like endoscopy suites.

  • How is the Papillotome regulated, and what does that mean for its use?

    The Papillotome holds FDA 510(k) clearance (K962346), meaning it has been deemed *substantially equivalent* to a legally marketed device in its category. This classification ensures it meets regulatory standards for endoscopic accessories in gastroenterology and urology, but it does not imply approval for specific clinical indications—only that it follows established safety and performance criteria for its intended electrosurgical use.

  • What safety considerations should be followed when handling the Papillotome?

    Since the Papillotome is an electrosurgical device, it requires strict adherence to electrosurgical safety protocols during use. It is non-sterile as supplied and must be sterilized between procedures to prevent contamination. Proper grounding, insulation checks, and adherence to manufacturer guidelines are critical to avoid risks like burns or electrical hazards in the endoscopy suite.