Cleared Traditional

K083802 - SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025

K083802 is an FDA 510(k) clearance for SONOTIP II 25-GAUGE ULTRASOUND NEEDLE S..., 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 88-day FDA review.

K083802 · Medi-Globe Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
88d
Days
Class 2
Risk

K083802 is an FDA 510(k) clearance for the SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01.... 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 March 20, 2009 after a review of 88 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 - K083802

510(k) Number K083802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2008
Decision Date March 20, 2009
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 131d · This submission: 88d
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 92
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K083802.
ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O
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K092359 · Cook Ireland, Ltd. · Nov 2009
MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM
K091257 · Medi-Globe Corporation · May 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
TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE
K073399 · Envisioneering, LLC · Dec 2007