Home / 510(k) Clearances / K153706

510(k) K153706

Insulin Pen Needle by SteriLance Medical (Suzhou), Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2016
Date Received
December 23, 2015
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 SteriLance Medical (Suzhou), Inc.

  • K244036 — Heel Incision Safety Lancet (SteriHeel 2) (February 26, 2025)
  • K244031 — Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposab (February 26, 2025)
  • K233796 — Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disp (January 16, 2024)
  • K221521 — Disposable Safety Lancet (October 28, 2022)
  • K221507 — Disposable Blood Lancet (August 31, 2022)
  • K221970 — Lancing device (August 30, 2022)
  • K210745 — Heel Incision Safety Lancet (August 26, 2021)

Other clearances for product code FMI

  • K252886 — Pen Needle (January 6, 2026)
  • K250700 — Pen Injector Needle 32.5 (November 21, 2025)
  • K252631 — Profoject™ Disposable Needle (October 16, 2025)
  • K250724 — Intraosseous Infusion Needles (July 30, 2025)
  • K250284 — TSK SELECT™ Needle (July 24, 2025)
  • K251447 — K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) (July 8, 2025)
  • K243309 — 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) (May 29, 2025)
  • K240355 — FROG (Filter Removal of Glass) (April 18, 2025)
  • K243581 — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (April 4, 2025)
  • K250658 — SureFine Pen Needle (April 3, 2025)