Cleared Traditional

K981889 - WORLDWIDE MEDICAL TECHNOLOGIES INTRODUC...

K981889 is an FDA 510(k) clearance for WORLDWIDE MEDICAL TECHNOLOGIES INTRODUC..., manufactured by Worldwide Medical Technologies, LLC. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K981889 · Worldwide Medical Technologies, LLC · Gastroenterology & Urology device
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Jul 1998
Decision
63d
Days
Class 2
Risk

K981889 is an FDA 510(k) clearance for the WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Worldwide Medical Technologies, LLC (Woodbury, US). The FDA issued a Cleared decision on July 31, 1998 after a review of 63 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 Worldwide Medical Technologies, LLC devices

FDA 510(k) Submission Details - K981889

510(k) Number K981889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1998
Decision Date July 31, 1998
Days to Decision 63 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 130d · This submission: 63d
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 55
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K981889.
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836
K012864 · Boston Scientific Corp · Oct 2001
WILSON-COOK ULTRASOUND BIOPSY NEEDLE
K013356 · Wilson-Cook Medical, Inc. · Oct 2001
OLYMPUS NA-10J-KB ASPIRATION NEEDLE
K991672 · Olympus America, Inc. · Nov 1999
MRI NEEDLES
K963565 · Cook, Inc. · Jul 1997
COAXIAL NEEDLE
K971842 · United States Endoscopy Group, Inc. · Jun 1997
OLYMPUS NA-10J-1 ASPIRATION NEEDLE
K970563 · Olympus America, Inc. · Apr 1997