Cleared Traditional

SandShark Injectable Anchor (SIA) System

K191466 · Stimwave Technologies, Inc. · Neurology
Nov 2019
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K191466 is an FDA 510(k) clearance for the SandShark Injectable Anchor (SIA) System, a Stimulator, Spinal-cord, Implanted (pain Relief) (Class II — Special Controls, product code GZB), submitted by Stimwave Technologies, Inc. (Pompano Beach, US). The FDA issued a Cleared decision on November 7, 2019, 157 days after receiving the submission on June 3, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5880.

Submission Details

510(k) Number K191466 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2019
Decision Date November 07, 2019
Days to Decision 157 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZB — Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5880

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