Cleared Traditional

K963565 - MRI NEEDLES

K963565 is an FDA 510(k) clearance for MRI NEEDLES, manufactured by Cook, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K963565 · Cook, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
312d
Days
Class 2
Risk

K963565 is an FDA 510(k) clearance for the MRI NEEDLES. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on July 14, 1997 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cook, Inc. devices

FDA 510(k) Submission Details - K963565

510(k) Number K963565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1996
Decision Date July 14, 1997
Days to Decision 312 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
181d slower than avg
Panel avg: 131d · This submission: 312d
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 85
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K963565.
MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM
K990220 · Medi-Globe Corp. · Mar 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
COAXIAL NEEDLE
K971842 · United States Endoscopy Group, Inc. · Jun 1997
OLYMPUS NA-10J-1 ASPIRATION NEEDLE
K970563 · Olympus America, Inc. · Apr 1997
SMARTGUIDE
K963894 · Ferguson Medical · Mar 1997