SandShark Injectable Anchor (SIA) System

Stimulator, Spinal-cord, Implanted (pain Relief)

Stimwave Technologies Inc.

The following data is part of a premarket notification filed by Stimwave Technologies Inc. with the FDA for Sandshark Injectable Anchor (sia) System.

Pre-market Notification Details

Device IDK191466
501k NumberK191466
Device Name:SandShark Injectable Anchor (SIA) System
ClassificationStimulator, Spinal-cord, Implanted (pain Relief)
Applicant Stimwave Technologies Inc. 1310 Park Central Boulevard South Pompano Beach,  FL  33064
ContactElizabeth Greene
CorrespondentElizabeth Greene
Stimwave Technologies Inc. 1310 Park Central Boulevard South Pompano Beach,  FL  33064
Product CodeGZB  
CFR Regulation Number882.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
501k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-03
Decision Date2019-11-07

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