Cleared Traditional

K103668 - BNX FINE NEEDLE ASPIRATION SYSTEM

K103668 is an FDA 510(k) clearance for BNX FINE NEEDLE ASPIRATION SYSTEM, manufactured by Boston Endoscopic Engineering. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K103668 · Boston Endoscopic Engineering · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
14d
Days
Class 2
Risk

K103668 is an FDA 510(k) clearance for the BNX FINE NEEDLE ASPIRATION SYSTEM. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Boston Endoscopic Engineering (Foster, US). The FDA issued a Cleared decision on December 30, 2010 after a review of 14 days - a notably fast clearance cycle.

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: 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 Boston Endoscopic Engineering devices

FDA 510(k) Submission Details - K103668

510(k) Number K103668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2010
Decision Date December 30, 2010
Days to Decision 14 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 130d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FCG Device Classification - Class 2, Special Controls

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 55
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K103668.
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
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K100712 · Boston Scientific Corporation · Mar 2010
ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O
K093195 · Cook Ireland, Ltd. · Jan 2010
ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A
K092359 · Cook Ireland, Ltd. · Nov 2009