Freedom Spinal Cord Stimulator System— 510(k) K150517

Clearance details

Applicant

Stimwave Technologies Incorporated

Product code

Code GZB

Device class

Class 2

Regulation

21 CFR 882.5880

Advisory panel

Neurology

Date received

2015-03-02

Decision date

2015-06-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Miami Beach, FL, US

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• K172644 — Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base2017-11-03
• K170141 — Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit2017-05-02
• K162161 — Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit2016-12-16

Death

4

Injury

1,879

Other

2

Total

1,885

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →