Cleared Traditional

K133008 - BNX DELIVERY SYSTEM PRE-LOADED WITH 19

K133008 is an FDA 510(k) clearance for BNX DELIVERY SYSTEM PRE-LOADED WITH 19, manufactured by Beacon Endoscopic. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K133008 · Beacon Endoscopic · Gastroenterology & Urology device
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Nov 2013
Decision
56d
Days
Class 2
Risk

K133008 is an FDA 510(k) clearance for the BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 .... Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Beacon Endoscopic (Auburndale, US). The FDA issued a Cleared decision on November 20, 2013 after a review of 56 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 Beacon Endoscopic devices

FDA 510(k) Submission Details - K133008

510(k) Number K133008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2013
Decision Date November 20, 2013
Days to Decision 56 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 130d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
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