FDA 510(k)

NIPRO SAFETOUCH II GAMMA

K-Number: K063721 · 2007-01-12

Decision Date2007-01-12

Product CodeFIE

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

NIPRO SAFETOUCH II GAMMA is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corp.. It received FDA 510(k) clearance on 2007-01-12 under 510(k) number K063721. The device is classified under product code FIE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIPRO SAFETOUCH II GAMMA?

NIPRO SAFETOUCH II GAMMA is a medical device that received FDA 510(k) clearance on 2007-01-12. The listed applicant is Nipro Medical Corp.. The 510(k) number is K063721.

When did NIPRO SAFETOUCH II GAMMA receive FDA 510(k) clearance?

NIPRO SAFETOUCH II GAMMA received FDA 510(k) clearance on 2007-01-12, under 510(k) number K063721.

Who is the listed applicant for NIPRO SAFETOUCH II GAMMA?

The FDA 510(k) record lists Nipro Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIPRO SAFETOUCH II GAMMA?

The FDA product code for NIPRO SAFETOUCH II GAMMA is FIE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Nipro Medical Corp. as applicant

K093985NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE K081210NIPRO SAFETOUCH HUBER INFUSTION SET K072024NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 K063368NIPRO BIOHOLE NEEDLE K052474NIPRO HYPODERMIC NEEDLE K051574NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE

View all 27 devices →

Related Devices (Code: FIE)

K253469Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)Mozarc Medical Us, LLC K251877JMS CAVEO A.V. Fistula Needle SetJMS North America Corporation K213015DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.K171505Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)Dimesol, Inc.K163025DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.K112734APLAN A.V. FISTULA NEEDLE SETAplan Well Enterprise Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.