Cleared Traditional

K880343 - BURNEY GALLBLADDER CATHETER KIT

K880343 is an FDA 510(k) clearance for BURNEY GALLBLADDER CATHETER KIT, manufactured by Mallinckrodt Critical Care. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 461-day FDA review.

K880343 · Mallinckrodt Critical Care · Gastroenterology & Urology device
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May 1989
Decision
461d
Days
Class 2
Risk

K880343 is an FDA 510(k) clearance for the BURNEY GALLBLADDER CATHETER KIT. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (St Louis, US). The FDA issued a Cleared decision on May 1, 1989 after a review of 461 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Mallinckrodt Critical Care devices

FDA 510(k) Submission Details - K880343

510(k) Number K880343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1988
Decision Date May 01, 1989
Days to Decision 461 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
330d slower than avg
Panel avg: 131d · This submission: 461d
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 411
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K880343.
WILSON-COOK GIANTURCO-ROSCH BILIARY Z STENT
K896069 · Wilson-Cook Medical, Inc. · Dec 1989
BILIARY ENDOPROSTHESIS FOR INTERNAL DRAINAGE SET
K892383 · Porges Corp. · May 1989
BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER
K892384 · Porges Corp. · May 1989
COOK-GIANTURCO BILIARY Z STENT
K882610 · Cook, Inc. · Apr 1989
EXPANDABLE BILIARY STENT ENDOPROSTHESIS
K885180 · Schneider Intl., Ltd. · Feb 1989
MODIFIED COPE SUTURE ANCHOR
K873606 · Cook, Inc. · Jun 1988