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510(k) K151017

JMS Harmony A.V. Fistula Needle Set by JMS North America Corporation — Product Code FIE

K151017 is an FDA 510(k) premarket notification submitted by JMS North America Corporation for the device "JMS Harmony A.V. Fistula Needle Set". The FDA issued a decision of Substantially Equivalent on May 13, 2015. 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
May 13, 2015
Date Received
April 16, 2015
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)
  • 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)
  • K111948 — WINGEATER V2 (October 24, 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)
  • 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)
  • K111948 — WINGEATER V2 (October 24, 2011)

FDA data resources