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510(k) K240253

Reach Needle by Aerin Medical, Inc. — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2024
Date Received
January 30, 2024
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 Aerin Medical, Inc.

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  • K221907 — RhinAer® Stylus (FG1393) (July 29, 2022)
  • K200300 — VivAer Stylus (April 13, 2020)
  • K192471 — RHIN1 Stylus (December 20, 2019)
  • K172529 — Vivaer ARC Stylus (December 5, 2017)
  • K162810 — InSeca ARC Stylus, Aerin Console (January 11, 2017)
  • K161994 — Aerin Medical Stylus (September 22, 2016)
  • K150637 — Aerin Medical Wand Model FG011 (November 19, 2015)

Other clearances for product code BSP

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  • K243682 — SonoPlex STIM; SonoPlex II (June 27, 2025)
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  • K243525 — SonoTAP and SonoTAP II (March 24, 2025)
  • K241953 — SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (November 22, 2024)
  • K241954 — SonoBlock; SonoBlock II (September 11, 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)