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FDA 510(k)

WINGEATER V2

K-Number: K111948 · 2011-10-24

ApplicantJMS North America Corporation
Decision Date2011-10-24
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WINGEATER 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 2011-10-24 under 510(k) number K111948. 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 WINGEATER V2?

WINGEATER V2 is a medical device that received FDA 510(k) clearance on 2011-10-24. The listed applicant is JMS North America Corporation. The 510(k) number is K111948.

When did WINGEATER V2 receive FDA 510(k) clearance?

WINGEATER V2 received FDA 510(k) clearance on 2011-10-24, under 510(k) number K111948.

Who is the listed applicant for WINGEATER 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 WINGEATER V2?

The FDA product code for WINGEATER V2 is FIE.

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Other records listing JMS North America Corporation as applicant

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.

K251877JMS CAVEO A.V. Fistula Needle SetK172499NEOSHIELDK121488JMS SAFE WING CATH (SWC)K112178JMS APHERESIS NEEDLE SET WINGEATER(R) V2K110157SYSLOC MINI V3

Related Devices (Code: FIE)

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.

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, LLCK251877JMS CAVEO A.V. Fistula Needle SetJMS North America CorporationK213015DORA 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.

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