Cleared Traditional

K971295 - AVE BRIDGE STENT SYSTEM

K971295 is an FDA 510(k) clearance for AVE BRIDGE STENT SYSTEM, manufactured by Arterial Vascular Engineering, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K971295 · Arterial Vascular Engineering, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
212d
Days
Class 2
Risk

K971295 is an FDA 510(k) clearance for the AVE BRIDGE STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Arterial Vascular Engineering, Inc. (Santa Rosa, US). The FDA issued a Cleared decision on November 5, 1997 after a review of 212 days - an extended review cycle.

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 Arterial Vascular Engineering, Inc. devices

FDA 510(k) Submission Details - K971295

510(k) Number K971295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1997
Decision Date November 05, 1997
Days to Decision 212 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 130d · This submission: 212d
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 314
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K971295.
COURIER ST BALLOON DILATATION CATHETER
K973008 · Boston Scientific Corp · Dec 1997
URESIL GUIDEWIRE
K972582 · Uresil Corp. · Nov 1997
MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM
K973113 · Boston Scientific Corp · Nov 1997
OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB
K972825 · Cordis Corp. · Oct 1997
URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S
K972583 · Uresil Corp. · Aug 1997
BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS
K965147 · Boston Scientific Corp · Jun 1997