510(k) K200482
K200482 is an FDA 510(k) premarket notification submitted by Bioness, Inc. for the device "StimRouter Neuromodulation System". The FDA issued a decision of Substantially Equivalent on March 27, 2020. The device falls under product code GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5870. Bioness, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2020
- Date Received
- February 27, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Peripheral Nerve, Implanted (Pain Relief)
- Device Class
- Class II
- Regulation Number
- 882.5870
- Review Panel
- NE
- Submission Type