Cleared Traditional

K151895 - Expect Pulmonary Endobronchial Ultrasou...

K151895 is the FDA 510(k) clearance for Expect Pulmonary Endobronchial Ultrasou... by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code FCG) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K151895 · Boston Scientific Corporation · Gastroenterology & Urology device
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Oct 2015
Decision
104d
Days
Class 2
Risk

K151895 is an FDA 510(k) clearance for the Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on October 22, 2015 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Boston Scientific Corporation devices

Submission Details

510(k) Number K151895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2015
Decision Date October 22, 2015
Days to Decision 104 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
26d faster than avg
Panel avg: 130d · This submission: 104d
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 54
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K151895.
Single Use Aspiration Needle NA-U401SX
K160098 · Olympus Medical Systems Corp. · Mar 2016
Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle
K160229 · Cook Ireland, Ltd. · Mar 2016
Single Use Aspiration Needle NA-U200H
K151738 · Olympus Medical Systems Corp. · Nov 2015
Corvocet Coaxial Introducer
K151373 · Merit Medical Systems, Inc. · Aug 2015
Echotip Procore HD Ultrasound Biopsy Needle
K142688 · Cook Ireland, Ltd. · Dec 2014
TISSUE SAMPLING NEEDLE
K103694 · United States Endoscopy Group, Inc. · Jul 2011