Home / 510(k) Clearances / K100520

510(k) K100520

NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER by Nipro Medical Corporation — Product Code FIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2010
Date Received
February 23, 2010
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 Nipro Medical Corporation

  • K222852 — Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle (May 25, 2023)
  • K212677 — aboNT SYRINGE (April 15, 2022)
  • K190037 — Cronus HP PTA Balloon Catheter (October 24, 2019)
  • K191359 — Nipro Syringe (October 9, 2019)
  • K182940 — Surdial DX Hemodialysis System (July 19, 2019)
  • K173029 — Nipro Syringe (March 30, 2018)
  • K161681 — Nipro SafeTouch IV Catheter (March 8, 2017)
  • K160444 — FB-U Hemodialyzer (February 8, 2017)
  • K151141 — Cronus HP - High Pressure Peripheral Balloon Catheter (January 14, 2016)
  • K140191 — ELISIO-H HEMODIALYZER (April 14, 2014)

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)