Cleared Traditional

K973113 - MODIFIED OLBERT BALLOON CATHETER SYSTEM

K973113 is the FDA 510(k) clearance for MODIFIED OLBERT BALLOON CATHETER SYSTEM by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K973113 · Boston Scientific Corp · Gastroenterology & Urology device
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Nov 1997
Decision
82d
Days
Class 2
Risk

K973113 is an FDA 510(k) clearance for the MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SY.... Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on November 10, 1997 after a review of 82 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 Boston Scientific Corp devices

Submission Details

510(k) Number K973113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1997
Decision Date November 10, 1997
Days to Decision 82 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
48d faster than avg
Panel avg: 130d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 298
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K973113.
MANAN(TM) INTRODUCER SHEATH/NEEDLE
K974815 · Medical Device Technologies, Inc. · Jan 1998
COURIER ST BALLOON DILATATION CATHETER
K973008 · Boston Scientific Corp · Dec 1997
URESIL GUIDEWIRE
K972582 · Uresil 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