FDA 510(k)

JMS APHERESIS NEEDLE SET WINGEATER(R) V2

K-Number: K112178 · 2011-10-27

Decision Date2011-10-27

Product CodeFIE

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

JMS APHERESIS NEEDLE SET WINGEATER(R) V2 is the device name listed in this FDA 510(k) record. The listed applicant is JMS North America Corporation. It received FDA 510(k) clearance on 2011-10-27 under 510(k) number K112178. 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 JMS APHERESIS NEEDLE SET WINGEATER(R) V2?

JMS APHERESIS NEEDLE SET WINGEATER(R) V2 is a medical device that received FDA 510(k) clearance on 2011-10-27. The listed applicant is JMS North America Corporation. The 510(k) number is K112178.

When did JMS APHERESIS NEEDLE SET WINGEATER(R) V2 receive FDA 510(k) clearance?

JMS APHERESIS NEEDLE SET WINGEATER(R) V2 received FDA 510(k) clearance on 2011-10-27, under 510(k) number K112178.

Who is the listed applicant for JMS APHERESIS NEEDLE SET WINGEATER(R) V2?

The FDA 510(k) record lists JMS North America Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JMS APHERESIS NEEDLE SET WINGEATER(R) V2?

The FDA product code for JMS APHERESIS NEEDLE SET WINGEATER(R) V2 is FIE.

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Other records listing JMS North America Corporation as applicant

K251877JMS CAVEO A.V. Fistula Needle Set K172499NEOSHIELD K121488JMS SAFE WING CATH (SWC)K111948WINGEATER V2 K110157SYSLOC MINI V3

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.