Cleared Traditional

K896391 - BARD/ANGIOMED STENTS

K896391 is an FDA 510(k) clearance for BARD/ANGIOMED STENTS, manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K896391 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
143d
Days
Class 2
Risk

K896391 is an FDA 510(k) clearance for the BARD/ANGIOMED STENTS. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on March 29, 1990 after a review of 143 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K896391

510(k) Number K896391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1989
Decision Date March 29, 1990
Days to Decision 143 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 131d · This submission: 143d
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 395
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K896391.
TELEMED ERCP CANNULA
K901431 · Telemed Systems, Inc. · Jun 1990
CANDELA DIRECTABLE BILIARY CATHETER SYSTEM
K900904 · Candela Laser Corp. · May 1990
WILSON-COOK ENDOSCOPIC NASAL BILIARY DRAINAGE SETS
K896323 · Wilson-Cook Medical, Inc. · Apr 1990
DOBBHOFF(R) ERCP CANNULA
K896518 · Biosearch Medical Products, Inc. · Feb 1990
PORGES ERCP CATHETERS
K896503 · Porges Corp. · Jan 1990
PORGES 2-WAY BALLOON EXTRACTION CATHETER
K896504 · Porges Corp. · Jan 1990