Cleared Traditional

Howell Biliary Introducer Needle (K160890) - FDA 510(k) Clearance

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

K160890 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Jun 2017
Decision
440d
Days
Class 2
Risk

K160890 is an FDA 510(k) clearance for the Howell Biliary Introducer Needle. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on June 14, 2017 after a review of 440 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - 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 Wilson-Cook Medical, Inc. devices

Submission Details

510(k) Number K160890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2016
Decision Date June 14, 2017
Days to Decision 440 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
310d slower than avg
Panel avg: 130d · This submission: 440d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FCG Biopsy Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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 - FCG Biopsy Needle

All 41
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K160890.
Single Use Aspiration Needle NA-U200H
K180449 · Olympus Medical Systems Corp. · Jun 2018
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K180037 · Covidien, LLC · Apr 2018
ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle
K171596 · Wilson-Cook Medical, Inc. · Aug 2017
Single Use Aspiration Needle NA-U401SX
K160098 · Olympus Medical Systems Corp. · Mar 2016
Single Use Aspiration Needle NA-U200H
K151738 · Olympus Medical Systems Corp. · Nov 2015
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K151895 · Boston Scientific Corporation · Oct 2015