Home / 510(k) Clearances / K022415

510(k) K022415

BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST by Waismed, Ltd. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2002
Date Received
July 24, 2002
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 Waismed, Ltd.

  • K211968 — NIO+ Adult (July 22, 2021)
  • K190538 — NIO-I (October 7, 2019)
  • K160805 — NIO-P (June 23, 2016)
  • K142086 — NIO -INTRAOSSEOUS DEVICE (August 28, 2014)
  • K062940 — BONE INJECTION GUN (B.I.G.) (December 22, 2006)
  • K981853 — BONE INJECTION GUN (B.I.G.) DEVICE (November 17, 1998)

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)