Cleared Traditional

K884714 - BILIARY DIALATOR

K884714 is an FDA 510(k) clearance for BILIARY DIALATOR, manufactured by Primrose Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K884714 · Primrose Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1989
Decision
325d
Days
Class 2
Risk

K884714 is an FDA 510(k) clearance for the BILIARY DIALATOR. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Primrose Medical, Inc. (Woburn, US). The FDA issued a Cleared decision on September 29, 1989 after a review of 325 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Primrose Medical, Inc. devices

FDA 510(k) Submission Details - K884714

510(k) Number K884714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1988
Decision Date September 29, 1989
Days to Decision 325 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
194d slower than avg
Panel avg: 131d · This submission: 325d
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 K884714.
WILTEK E.R.C.P. CATHETER
K894867 · Wiltek Medical, Inc. · Dec 1989
WILTEK BILIARY STENT SET
K894871 · Wiltek Medical, Inc. · Dec 1989
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
BURNEY GALLBLADDER CATHETER KIT
K880343 · Mallinckrodt Critical Care · May 1989