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510(k) K223854

Unistik® ShieldLock, Unistik VacuFlip by Owen Mumford, Ltd. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2023
Date Received
December 23, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Owen Mumford, Ltd.

  • K231124 — Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), (June 27, 2023)
  • K222168 — Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and (November 3, 2022)
  • K222303 — Unistik® Pro (October 25, 2022)
  • K221613 — Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets (October 3, 2022)
  • K222111 — Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G (September 7, 2022)
  • K221126 — Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single- (August 12, 2022)
  • K210399 — Unifine SafeControl (September 17, 2021)
  • K173881 — Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G (July 11, 2018)
  • K152339 — Unifine Pentips/ Unifine Pentips Plus (June 24, 2016)
  • K122837 — AUTOJECT 2 FOR GLASSY SYRINGE (October 15, 2012)

Other clearances for product code JKA

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  • K251812 — Steripath® Flow™ Blood Collection System (September 25, 2025)
  • K243207 — BD Vacutainer® Eclipse™ Blood Collection Needle (July 3, 2025)
  • K250961 — Blood collection tube holders (June 4, 2025)
  • K244047 — Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) (May 23, 2025)
  • K250907 — Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set (April 30, 2025)
  • K243649 — BD Vacutainer® Multiple Sample Luer Adapter (March 21, 2025)
  • K241586 — PIVO™ Pro Needle-free Blood Collection Device (February 27, 2025)
  • K242320 — BD Vacutainer® One Use Holder (November 1, 2024)
  • K233979 — VACUETTE® QUICKSHIELD Complete (Plus) (July 19, 2024)