Cleared Traditional

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

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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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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 131d · 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 Consultant

Intertek Testing Services
JAY Y KOGOMA

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FCG Biopsy Needle

All 92
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K091257.
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
SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025
K083802 · Medi-Globe Corporation · Mar 2009
ECHOTIP ULTRA ULTRASOUND NEEDLE
K083330 · Cook Endoscopy · Feb 2009
BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818
K081323 · B-K Medical Aps · Jul 2008

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.