Cleared Traditional

K940965 - ELIMINATOR BALLOON DILATOR

K940965 is an FDA 510(k) clearance for ELIMINATOR BALLOON DILATOR, 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 79-day FDA review.

K940965 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
79d
Days
Class 2
Risk

K940965 is an FDA 510(k) clearance for the ELIMINATOR BALLOON DILATOR. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on May 20, 1994 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K940965

510(k) Number K940965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1994
Decision Date May 20, 1994
Days to Decision 79 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 131d · This submission: 79d
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 477
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K940965.
WALLSTENT BILIARY ENDOPROTHESES
K923993 · Schneider U.S. Stent Div. · Sep 1994
MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH
K930623 · Boston Scientific Corp · Sep 1994
AMERICAN CATHETER E.R.C.P. CANNULA
K940370 · Intl. Medical, Inc. · Aug 1994
INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D.
K934377 · Interventional Thermodynamics, Inc. · Feb 1994
HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS
K924608 · Boston Scientific Corp · Jan 1994
INTHERM STASIS VALVE SYSTEM
K931025 · Interventional Therapeutics Corp. · Sep 1993
K940965 · ELIMINATOR BALLOON DILATOR
Download PDF FDA Summary C.R. Bard, Inc.