FDA 510(k)

NIPRO BIOHOLE NEEDLE

K-Number: K063368 · 2007-02-05

Decision Date2007-02-05

Product CodeFIE

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

NIPRO BIOHOLE NEEDLE 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 2007-02-05 under 510(k) number K063368. 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 BIOHOLE NEEDLE?

NIPRO BIOHOLE NEEDLE is a medical device that received FDA 510(k) clearance on 2007-02-05. The listed applicant is Nipro Medical Corp.. The 510(k) number is K063368.

When did NIPRO BIOHOLE NEEDLE receive FDA 510(k) clearance?

NIPRO BIOHOLE NEEDLE received FDA 510(k) clearance on 2007-02-05, under 510(k) number K063368.

Who is the listed applicant for NIPRO BIOHOLE NEEDLE?

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 BIOHOLE NEEDLE?

The FDA product code for NIPRO BIOHOLE NEEDLE is FIE.

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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 K063721NIPRO SAFETOUCH II GAMMA K052474NIPRO HYPODERMIC NEEDLE K051574NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE

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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

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