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FDA 510(k)

SandShark Injectable Anchor (SIA) System

K-Number: K191466 · 2019-11-07

ApplicantStimwave Technologies, Inc.
Decision Date2019-11-07
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SandShark Injectable Anchor (SIA) System is a medical device manufactured by Stimwave Technologies, Inc.. It received FDA 510(k) clearance on 2019-11-07 under approval number K191466. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SandShark Injectable Anchor (SIA) System?

SandShark Injectable Anchor (SIA) System is a medical device that received FDA 510(k) clearance on 2019-11-07. It is manufactured by Stimwave Technologies, Inc.. The 510(k) number is K191466.

When was SandShark Injectable Anchor (SIA) System approved by the FDA?

SandShark Injectable Anchor (SIA) System received FDA 510(k) clearance on 2019-11-07, under approval number K191466.

What company makes SandShark Injectable Anchor (SIA) System?

SandShark Injectable Anchor (SIA) System is manufactured by Stimwave Technologies, Inc..

What is the FDA product code for SandShark Injectable Anchor (SIA) System?

The FDA product code for SandShark Injectable Anchor (SIA) System is GZB.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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