Cleared Traditional

Reach Needle

K240253 · Aerin Medical, Inc. · Anesthesiology
Mar 2024
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K240253 is an FDA 510(k) clearance for the Reach Needle, a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II — Special Controls, product code BSP), submitted by Aerin Medical, Inc. (Mountain View,, US). The FDA issued a Cleared decision on March 21, 2024, 51 days after receiving the submission on January 30, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K240253 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2024
Decision Date March 21, 2024
Days to Decision 51 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSP — Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5150

Similar Devices — BSP Needle, Conduction, Anesthetic (w/wo Introducer)

All 151
SonoMSK
K243690 · PAJUNK GmbH Medizintechnologie · Jul 2025
SonoPlex STIM; SonoPlex II
K243682 · PAJUNK GmbH Medizintechnologie · Jun 2025
SPROTTE? STANDARD (LUER/ NRFit?) Lumbar Puncture
K250774 · PAJUNK GmbH Medizintechnologie · Jun 2025
SonoTAP and SonoTAP II
K243525 · PAJUNK GmbH Medizintechnologie · Mar 2025
SPROTTE? STANDARD (LUER/ NRFit?) Anesthesiology
K241953 · PAJUNK GmbH Medizintechnologie · Nov 2024
SonoBlock; SonoBlock II
K241954 · PAJUNK GmbH Medizintechnologie · Sep 2024