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510(k) K002352

JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE by Jms Co., Ltd. — Product Code FIE

K002352 is an FDA 510(k) premarket notification submitted by Jms Co., Ltd. for the device "JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE". The FDA issued a decision of Substantially Equivalent on September 6, 2001. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. Jms Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2001
Date Received
August 2, 2000
Clearance Type
Traditional
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 Co., Ltd.

  • K002394 — JMS APHERESIS NEEDLE SET ACCORDION TYPE (September 5, 2001)
  • K010406 — JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G (June 20, 2001)
  • K010410 — JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G (June 20, 2001)
  • K000845 — MODIFICATION TO JMS A.V. FISTULA NEEDLE SET (April 10, 2000)
  • K000843 — MODIFICATION TO JMS APHERESIS NEEDLE (April 10, 2000)
  • K991904 — MODIFICATION OF JMS NEEDLES AND JMS SYRINGES (August 31, 1999)
  • K990510 — JMS APHERESIS NEEDLE (August 30, 1999)
  • K990470 — JMS A. V. FISTULA NEEDLE SET (August 30, 1999)
  • K983707 — JMS DIALYZER PRIMING SET (January 8, 1999)
  • K974902 — JMS APHERESIS NEEDLE (March 30, 1998)

Other clearances for product code FIE

  • K253469 — Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritu (August 6, 2026)
  • 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)

FDA data resources