FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Soniquence Bipolar Electrodes
K Number: K190336
·
Decision Jun 20, 2019
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
6
Review Days
126
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Basic Information
- Device Name
- Soniquence Bipolar Electrodes
- K Number
- K190336
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Soniquence, LLC
- Date Received
- February 14, 2019
- Decision Date
- June 20, 2019
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Soniquence, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K254220 | Reusable 3 Button Fingerswitch Wand | Jan 27, 2026 | Substantially Equivalent |
| K212222 | Soniquence Reusable 3 Button Fingerswitch Wand | Sep 2, 2022 | Substantially Equivalent |
| K220071 | Soniquence Reusable Neutral Plate | Feb 3, 2022 | Substantially Equivalent |
| K211946 | Soniquence Reusable Bipolar Cable | Jul 16, 2021 | Substantially Equivalent |
| K183611 | Soniquence RF Generator and Soniquence Electrodes | May 22, 2019 | Substantially Equivalent |