Cleared Traditional

OLBERT CATHETER SYSTEM FOR BILIARY TRACT DILATATIO (K851647) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K851647 · Meadox Surgimed, Inc. · Gastroenterology & Urology device
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Jul 1985
Decision
72d
Days
Class 2
Risk

K851647 is an FDA 510(k) clearance for the OLBERT CATHETER SYSTEM FOR BILIARY TRACT DILATATIO. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Meadox Surgimed, Inc. (Oakland, US). The FDA issued a Cleared decision on July 3, 1985 after a review of 72 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 Meadox Surgimed, Inc. devices

Submission Details

510(k) Number K851647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1985
Decision Date July 03, 1985
Days to Decision 72 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 130d · This submission: 72d
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 181
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K851647.
BARD-PARKER BILIARY BALLOON CATHETER
K852293 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1985
DAVOL RETRIEVAL BALLOON CATHETER
K853543 · C.R. Bard, Inc. · Sep 1985
GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO
K851242 · Cook, Inc. · Sep 1985
USCI ENDOPROSTHESIS
K834574 · C.R. Bard, Inc. · Apr 1984