Cleared Traditional

K863437 - BARD BALLOON DILATATION SYSTEM

K863437 is an FDA 510(k) clearance for BARD BALLOON DILATATION SYSTEM, 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 54-day FDA review.

K863437 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1986
Decision
54d
Days
Class 2
Risk

K863437 is an FDA 510(k) clearance for the BARD BALLOON DILATATION SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on October 29, 1986 after a review of 54 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.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K863437

510(k) Number K863437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1986
Decision Date October 29, 1986
Days to Decision 54 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
77d faster than avg
Panel avg: 131d · This submission: 54d
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 K863437.
LINDEN STONE EXTRACTION BALLOON
K872509 · Hobbs Medical, Inc. · Sep 1987
SHEATH, ENDOSCOPE
K862059 · Endovations · Nov 1986
BILIARY BALLOON CATHETER
K863571 · Uresil Corp. · Nov 1986
LUNDERQUIST - RING PTC DRAINAGE CATHETER
K861220 · Meadox Surgimed, Inc. · May 1986
ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY
K860990 · Endovations · May 1986
ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY
K855142 · Angiomed U.S., Inc. · Mar 1986