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ERCP Cannula

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

Active United States

510(k) K924107

Overview

The Endoscopic Retrograde Cholangiopancreatography (ERCP) Cannula is a gastroenterology and urology device used during ERCP procedures to cannulate the bile duct or pancreatic duct for the identification of stones, tumors, or narrowings (strictures) in the biliary tree. The cannula is passed through the endoscope's working channel and into the ampulla of Vater.

This device is supplied by United States Endoscopy Group, Inc. and has received FDA 510(k) clearance under K924107. It is classified as a Class II device under regulation number 876.5010 and product code FGE, with intended use in gastroenterology and urology specialties.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK924107 Date30 Dec 1992ClearedStatusActive

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
FGE
Device Class
Class II
Regulation
21 CFR Part 876.5010
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from United States Endoscopy Group, Inc.

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Questions

  • What is the ERCP Cannula used for?

    The ERCP Cannula is used during endoscopic retrograde cholangiopancreatography (ERCP) procedures to cannulate the bile duct or pancreatic duct, allowing identification of stones, tumors, or narrowings (strictures) in the biliary tree.

  • How is the ERCP Cannula supplied and by whom?

    The ERCP Cannula is supplied by United States Endoscopy Group, Inc., as indicated in the device data, and is passed through the endoscope's working channel into the ampulla of Vater during use.

  • What regulatory pathway was used for the ERCP Cannula?

    The ERCP Cannula received FDA 510(k) clearance under K924107, which is a traditional clearance pathway, and is classified as a Class II device under regulation number 876.5010 with product code FGE.