Cleared Traditional

K012358 - CHIBA NEEDLE

K012358 is an FDA 510(k) clearance for CHIBA NEEDLE, manufactured by Ispg, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K012358 · Ispg, Inc. · Gastroenterology & Urology device
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Oct 2001
Decision
82d
Days
Class 2
Risk

K012358 is an FDA 510(k) clearance for the CHIBA NEEDLE. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Ispg, Inc. (New Milford, US). The FDA issued a Cleared decision on October 15, 2001 after a review of 82 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 Ispg, Inc. devices

FDA 510(k) Submission Details - K012358

510(k) Number K012358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2001
Decision Date October 15, 2001
Days to Decision 82 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
49d faster than avg
Panel avg: 131d · This submission: 82d
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 78
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K012358.
DISPOSABLE ASPIRATION NEEDLE NA-200H
K023272 · The Olympus Optical Co. · Dec 2002
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
AUTOMATED CORE BIOPSY DEVICE
K011270 · Promex, Inc. · Jun 2001
OLYMPUS NA-10J-KB ASPIRATION NEEDLE
K991672 · Olympus America, Inc. · Nov 1999
MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM
K990220 · Medi-Globe Corp. · Mar 1999