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510(k) K222852

Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle by Nipro Medical Corporation — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2023
Date Received
September 21, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Nipro Medical Corporation

  • 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)
  • K140136 — NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE (February 14, 2014)

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