Cleared Traditional

MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM

K091257 · Medi-Globe Corporation · Gastroenterology & Urology
May 2009
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K091257 is an FDA 510(k) clearance for the MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM, a Biopsy Needle (Class II — Special Controls, product code FCG), submitted by Medi-Globe Corporation (Tempe, US). The FDA issued a Cleared decision on May 8, 2009, 9 days after receiving the submission on April 29, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K091257 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code FCG — Biopsy Needle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1075

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