FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CANADY VIEIRA HYBRID PLASMA SCALPEL
K Number: K113500
·
Decision Dec 9, 2011
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
5
Review Days
14
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Basic Information
- Device Name
- CANADY VIEIRA HYBRID PLASMA SCALPEL
- K Number
- K113500
- 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
- Us Medical Innovations, LLC
- Date Received
- November 25, 2011
- Decision Date
- December 9, 2011
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- Y
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 Us Medical Innovations, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K240297 | Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS) | May 3, 2024 | Substantially Equivalent |
| K212736 | Canady Flex RoboWrist | Nov 22, 2022 | Substantially Equivalent |
| K192124 | Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories | Nov 21, 2019 | Substantially Equivalent |
| K100669 | CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES | Apr 6, 2011 | Substantially Equivalent |