Cleared Traditional

K091257 - MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE ...

K091257 is an FDA 510(k) clearance for MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE ..., manufactured by Medi-Globe Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K091257 · Medi-Globe Corporation · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
May 2009
Decision
9d
Days
Class 2
Risk

K091257 is an FDA 510(k) clearance for the MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Medi-Globe Corporation (Tempe, US). The FDA issued a Cleared decision on May 8, 2009 after a review of 9 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 Medi-Globe Corporation devices

FDA 510(k) Submission Details - K091257

510(k) Number K091257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2009
Decision Date May 08, 2009
Days to Decision 9 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
121d faster than avg
Panel avg: 130d · This submission: 9d
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 K091257.
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K093195 · Cook Ireland, Ltd. · Jan 2010
ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A
K092359 · Cook Ireland, Ltd. · Nov 2009
TROKABONE, TROKABONE STERNAL
K070179 · PAJUNK GmbH Medizintechnologie · Mar 2007
SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
K050503 · Olympus Medical Systems Corporation · May 2005
EASY CORE BIOPSY SYSTEM II
K050120 · Boston Scientific Corp · Feb 2005