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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 the device name listed in this FDA 510(k) record. The listed applicant is Stimwave Technologies, Inc.. It received FDA 510(k) clearance on 2019-11-07 under 510(k) 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. The listed applicant is Stimwave Technologies, Inc.. The 510(k) number is K191466.

When did SandShark Injectable Anchor (SIA) System receive FDA 510(k) clearance?

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

Who is the listed applicant for SandShark Injectable Anchor (SIA) System?

The FDA 510(k) record lists Stimwave Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Stimwave Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182720Freedom Spinal Cord Stimulator (SCS) SystemK180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitK172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading BaseK170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitK162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitK160600Freedom Spinal Cord Stimulator System

View all 7 devices →

Related Devices (Code: GZB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific NeuromodulationK221376Nalu Neurostimulation SystemBoston Scientific NeuromodulationK203547Nalu Neurostimulation SystemBoston Scientific NeuromodulationK202274Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kitsBoston Scientific NeuromodulationK201618Nalu Neurostimulation SCS systemBoston Scientific NeuromodulationK190960Nalu Lead Blank (50cm)Boston Scientific Neuromodulation

Official Source

View on FDA Database →

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

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