Home / 510(k) Clearances / K212982

510(k) K212982

Medispine - Spinal Needle, Glospine - Spinal Needle by Global Medikit Limited — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2022
Date Received
September 17, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type

Other clearances by Global Medikit Limited

  • K193158 — ACENT™ Central Venous Catheter (November 24, 2020)

Other clearances for product code BSP

  • K243690 — SonoMSK (July 1, 2025)
  • K243682 — SonoPlex STIM; SonoPlex II (June 27, 2025)
  • K250774 — SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture (June 25, 2025)
  • K243525 — SonoTAP and SonoTAP II (March 24, 2025)
  • K241953 — SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (November 22, 2024)
  • K241954 — SonoBlock; SonoBlock II (September 11, 2024)
  • K240253 — Reach Needle (March 21, 2024)
  • K211085 — BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle (July 1, 2022)
  • K210978 — BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle (December 22, 2021)
  • K203668 — RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal N (September 29, 2021)