FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
da Vinci E-200 Electrosurgical Generator
K Number: K241635
·
Decision Aug 5, 2024
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
17
Review Days
60
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Basic Information
- Device Name
- da Vinci E-200 Electrosurgical Generator
- K Number
- K241635
- 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
- Intuitive Surgical
- Date Received
- June 6, 2024
- Decision Date
- August 5, 2024
- 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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|---|---|---|---|
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| K231212 | da Vinci E-200 Electrosurgical Generator | Jun 21, 2023 | Substantially Equivalent |
| K223039 | da Vinci E-200 Electrosurgical Generator | Nov 28, 2022 | Substantially Equivalent |
| K192803 | da Vinci Xi Surgical System, da Vinci X Surgical System | Apr 29, 2020 | Substantially Equivalent |
| K191529 | da Vinci Xi Surgical System, da Vinci X Surgical System | Feb 6, 2020 | Substantially Equivalent |
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| K182643 | IRIS 1.0 System | Feb 22, 2019 | Substantially Equivalent |
| K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | Feb 14, 2019 | Substantially Equivalent |