Cleared Traditional

K991672 - OLYMPUS NA-10J-KB ASPIRATION NEEDLE

K991672 is the FDA 510(k) clearance for OLYMPUS NA-10J-KB ASPIRATION NEEDLE by Olympus America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FCG) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K991672 · Olympus America, Inc. · Gastroenterology & Urology device
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Nov 1999
Decision
170d
Days
Class 2
Risk

K991672 is an FDA 510(k) clearance for the OLYMPUS NA-10J-KB ASPIRATION NEEDLE. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on November 3, 1999 after a review of 170 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus America, Inc. devices

Submission Details

510(k) Number K991672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1999
Decision Date November 03, 1999
Days to Decision 170 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
40d slower than avg
Panel avg: 130d · This submission: 170d
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 54
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K991672.
MODIFICATION TO TEMNO BIOPSY NEEDLES
K024120 · Allegiance Healthcare Corp. · Jan 2003
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
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