Cleared Special

NIPRO SAFETOUCH II GAMMA (K063721) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K063721 · Nipro Medical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 78
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K063721.
JMS CAVEO A.V. Fistula Needle Set
K251877 · JMS North America Corporation · Aug 2025
DORA Disposable A.V. Fistula Needle Sets
K213015 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Apr 2022
Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
K171505 · Dimesol, Inc. · May 2018
ARTERIOVENOUS FISTULA SETS
K900125 · Baxter Healthcare Corp · Jan 1990