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510(k) K111948

WINGEATER V2 by JMS North America Corporation — Product Code FIE

K111948 is an FDA 510(k) premarket notification submitted by JMS North America Corporation for the device "WINGEATER V2". The FDA issued a decision of Substantially Equivalent on October 24, 2011. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. JMS North America Corporation has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2011
Date Received
July 8, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Fistula
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by JMS North America Corporation

  • K251877 — JMS CAVEO A.V. Fistula Needle Set (August 15, 2025)
  • K172499 — NEOSHIELD (June 1, 2018)
  • K151017 — JMS Harmony A.V. Fistula Needle Set (May 13, 2015)
  • K142564 — JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle S (December 23, 2014)
  • K132321 — JMS SYRINGE (February 20, 2014)
  • K121488 — JMS SAFE WING CATH (SWC) (March 5, 2013)
  • K112178 — JMS APHERESIS NEEDLE SET WINGEATER(R) V2 (October 27, 2011)
  • K110157 — SYSLOC MINI V3 (February 11, 2011)

Other clearances for product code FIE

  • K251877 — JMS CAVEO A.V. Fistula Needle Set (August 15, 2025)
  • K213015 — DORA Disposable A.V. Fistula Needle Sets (April 8, 2022)
  • K171505 — Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposa (May 17, 2018)
  • K163025 — DORA Disposable A.V. Fistula Needle Sets (July 20, 2017)
  • K151017 — JMS Harmony A.V. Fistula Needle Set (May 13, 2015)
  • K131950 — ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET (January 16, 2015)
  • K142564 — JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle S (December 23, 2014)
  • K134019 — MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECT (September 11, 2014)
  • K112734 — APLAN A.V. FISTULA NEEDLE SET (April 24, 2012)
  • K112178 — JMS APHERESIS NEEDLE SET WINGEATER(R) V2 (October 27, 2011)

FDA data resources