Cleared Traditional

K990220 - MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM

K990220 is an FDA 510(k) clearance for MODIFICATION OF GIP/MEDI-GLOBE ULTRASOU..., manufactured by Medi-Globe Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K990220 · Medi-Globe Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
68d
Days
Class 2
Risk

K990220 is an FDA 510(k) clearance for the MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Medi-Globe Corp. (Tempe, US). The FDA issued a Cleared decision on March 31, 1999 after a review of 68 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 Corp. devices

FDA 510(k) Submission Details - K990220

510(k) Number K990220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1999
Decision Date March 31, 1999
Days to Decision 68 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
63d faster than avg
Panel avg: 131d · This submission: 68d
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 K990220.
WILSON-COOK ULTRASOUND BIOPSY NEEDLE
K013356 · Wilson-Cook Medical, Inc. · Oct 2001
AUTOMATED CORE BIOPSY DEVICE
K011270 · Promex, Inc. · Jun 2001
OLYMPUS NA-10J-KB ASPIRATION NEEDLE
K991672 · Olympus America, Inc. · Nov 1999
N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE
K983218 · Avid N.I.T., Inc. · Nov 1998
WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE
K981889 · Worldwide Medical Technologies, LLC · Jul 1998
MRI NEEDLES
K963565 · Cook, Inc. · Jul 1997