FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
StimRouter Neuromodulation System
K Number: K200482
·
Decision Mar 27, 2020
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
23
Applicant Total
13
Review Days
29
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- StimRouter Neuromodulation System
- K Number
- K200482
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioness, Inc.
- Date Received
- February 27, 2020
- Decision Date
- March 27, 2020
- Product Code
- GZF
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GZF), ordered by most recent decision date.
StimTrial Neuromodulation System
FDA 510(k)
FDA Class 2
·Neurology
TalisMann Neuromodulation System
FDA 510(k)
FDA Class 2
·Neurology
Nalu Neurostimulation System for Peripheral Nerve Stimulation
FDA 510(k)
FDA Class 2
·Neurology
Freedom Peripheral Nerve Stimulator (PNS) System
FDA 510(k)
FDA Class 2
·Neurology
Neuspera Nuity System
FDA 510(k)
FDA Class 2
·Neurology
StimRouter Neuromodulation System
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Bioness, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K211965 | StimRouter Neuromodulation System | Feb 23, 2022 | Substantially Equivalent |
| K200262 | L100 Go System | Mar 4, 2020 | Substantially Equivalent |
| K190047 | StimRouter Neuromodulation System | Oct 31, 2019 | Substantially Equivalent |
| K191587 | L360 Thigh System | Sep 12, 2019 | Substantially Equivalent |
| K190285 | L300 Go System | Mar 14, 2019 | Substantially Equivalent |
| K173682 | L300 Go System | Mar 9, 2018 | Substantially Equivalent |
| K162407 | L300 Go System | Jan 27, 2017 | Substantially Equivalent |
| K142432 | StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit | Feb 20, 2015 | Substantially Equivalent |
| K123636 | H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE | May 1, 2013 | Substantially Equivalent |
| K122784 | NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT | Dec 27, 2012 | Substantially Equivalent |