FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE
K Number: K100418
·
Decision Sep 3, 2010
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
130
Review Days
199
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
- SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE
- K Number
- K100418
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Covidien
- Date Received
- February 16, 2010
- Decision Date
- September 3, 2010
- Product Code
- GXY
- 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 |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXY), ordered by most recent decision date.
BioWave BioWraps
FDA 510(k)
FDA Class 2
·Neurology
Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
FDA 510(k)
FDA Class 2
·Neurology
MR Conditional Cup Electrodes
FDA 510(k)
FDA Class 2
·Neurology
Tutamen Self Adhesive Electrodes
FDA 510(k)
FDA Class 2
·Neurology
myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
FDA 510(k)
FDA Class 2
·Neurology
Ceribell Brain Monitor Headband
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Covidien
| K Number | Device Name | ||
|---|---|---|---|
| K241486 | Sofsilk Coated Braided Silk Suture | Dec 3, 2024 | Substantially Equivalent |
| K240077 | Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044) | Aug 20, 2024 | Substantially Equivalent |
| K231934 | GIA Stapler with Tri-Staple Technology | Oct 27, 2023 | Substantially Equivalent |
| K231240 | MaxTack Motorized Fixation Device | Sep 8, 2023 | Substantially Equivalent |
| K223130 | Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) | Aug 30, 2023 | Substantially Equivalent |
| K232126 | EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler Anvil | Aug 16, 2023 | Substantially Equivalent |
| K231491 | TA Stapler and Loading Unit with DST Series Technology | Aug 16, 2023 | Substantially Equivalent |
| K221629 | Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters) | Feb 22, 2023 | Substantially Equivalent |
| K221771 | EEA Circular Stapler with Tri-Staple Technology | Nov 30, 2022 | Substantially Equivalent |
| K222641 | Signia Small Diameter Reloads Including Regular (Round) Tip Version | Nov 29, 2022 | Substantially Equivalent |