Cleared Special

K063721 - NIPRO SAFETOUCH II GAMMA

K063721 is an FDA 510(k) clearance for NIPRO SAFETOUCH II GAMMA, manufactured by Nipro Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Special 510(k) pathway after a 28-day FDA review.

K063721 · Nipro Medical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Jan 2007
Decision
28d
Days
Class 2
Risk

K063721 is an FDA 510(k) clearance for the NIPRO SAFETOUCH II GAMMA. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Nipro Medical Corp. (Miami, US). The FDA issued a Cleared decision on January 12, 2007 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nipro Medical Corp. devices

FDA 510(k) Submission Details - K063721

510(k) Number K063721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2006
Decision Date January 12, 2007
Days to Decision 28 days
Submission Type Special
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
103d faster than avg
Panel avg: 131d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

FIE Device Classification - Class 2, Special Controls

Product Code FIE Needle, Fistula
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 - FIE Needle, Fistula

All 65
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K063721.
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MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE
K062953 · Medisystems Corp. · Feb 2007
NIPRO BIOHOLE NEEDLE
K063368 · Nipro Medical Corp. · Feb 2007
SUPERCATH V
K052267 · Togo Medikit Co., Ltd. · Oct 2006
JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET
K051814 · Jms North America Corp. · Aug 2005
JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE
K002352 · Jms Co., Ltd. · Sep 2001