Cleared Traditional

K083802 - SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025 (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K083802 · Medi-Globe Corporation · Gastroenterology & Urology device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 130d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 132
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K083802.
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
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K250994 · Finemedix Co., Ltd. · Aug 2025
EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)
K241209 · Cook Ireland, Ltd. · Jul 2024
Precision GI
K231422 · Limaca Medical, Ltd. · Aug 2023
ClearTip
K231267 · Finemedix Co., Ltd. · Jun 2023
EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
K230909 · Cook Ireland, Ltd. · May 2023