510(k) K150517
K150517 is an FDA 510(k) premarket notification submitted by Stimwave Technologies Incorporated for the device "Freedom Spinal Cord Stimulator System". The FDA issued a decision of Substantially Equivalent on June 5, 2015. The device falls under product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5880. Stimwave Technologies Incorporated has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 2015
- Date Received
- March 2, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Spinal-Cord, Implanted (Pain Relief)
- Device Class
- Class II
- Regulation Number
- 882.5880
- Review Panel
- NE
- Submission Type