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510(k) K250774

SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture by PAJUNK GmbH Medizintechnologie — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2025
Date Received
March 14, 2025
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 PAJUNK GmbH Medizintechnologie

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  • K243682 — SonoPlex STIM; SonoPlex II (June 27, 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)
  • K230701 — Stim2Go (November 24, 2023)
  • K230201 — Disposable Pre-calibrated Brain Biopsy Needle 2.0 (February 22, 2023)
  • K220897 — Disposable Brain Biopsy Needle 2.0 (August 17, 2022)
  • K202699 — E-Cath STIM acc. Tsui (December 29, 2020)
  • K190663 — Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 (June 17, 2019)

Other clearances for product code BSP

  • K243690 — SonoMSK (July 1, 2025)
  • K243682 — SonoPlex STIM; SonoPlex II (June 27, 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)
  • K212982 — Medispine - Spinal Needle, Glospine - Spinal Needle (July 29, 2022)
  • 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)