Cleared Traditional

K924107 - ERCP CANNULA

K924107 is an FDA 510(k) clearance for ERCP CANNULA, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K924107 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
139d
Days
Class 2
Risk

K924107 is an FDA 510(k) clearance for the ERCP CANNULA. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Waite Hill, US). The FDA issued a Cleared decision on December 30, 1992 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all United States Endoscopy Group, Inc. devices

FDA 510(k) Submission Details - K924107

510(k) Number K924107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1992
Decision Date December 30, 1992
Days to Decision 139 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 131d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FGE Stents, Drains And Dilators For The Biliary Ducts

All 382
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K924107.
HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS
K924608 · Boston Scientific Corp · Jan 1994
INTHERM STASIS VALVE SYSTEM
K931025 · Interventional Therapeutics Corp. · Sep 1993
URESIL BILLIARY CATHETER
K923096 · Uresil Corp. · Jul 1993
BARD BILIARY BALLOON DILATORS
K920361 · C.R. Bard, Inc. · Nov 1992
INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
K924451 · Interventional Therapeutics Corp. · Oct 1992
MCLEAN-STOCK PERCUTANEOUS T-TUBE SET
K921654 · Cook, Inc. · Jul 1992