Home / 510(k) Clearances / K172823

510(k) K172823

Portex NRFit Epidural Needles by Smiths Medical Asd, Inc. — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2018
Date Received
September 18, 2017
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 Smiths Medical Asd, Inc.

  • K232943 — Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe (May 31, 2024)
  • K210833 — Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Trach (November 26, 2021)
  • K211634 — Hypodermic Needle-Pro EDGE Safety Device (August 26, 2021)
  • K192375 — Intellifuse Administration and Intellifuse Blood Administration Sets (September 18, 2020)
  • K181699 — Level 1 Convective Warmer (July 26, 2018)
  • K172800 — Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point (June 14, 2018)
  • K172410 — Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of (June 1, 2018)
  • K172592 — CADD Yellow High Volume Administration Set with NRFit connector (May 17, 2018)
  • K173912 — BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Perc (May 8, 2018)
  • K171968 — EchoGlo Needle (January 25, 2018)

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)
  • 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)