FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
K Number: K240723
·
Decision May 24, 2024
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
163
Applicant Total
17
Review Days
67
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Basic Information
- Device Name
- da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
- K Number
- K240723
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intuitive Surgical
- Date Received
- March 18, 2024
- Decision Date
- May 24, 2024
- Product Code
- NAY
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| NAY | System, Surgical, Computer Controlled Instrument | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NAY), ordered by most recent decision date.
da Vinci Firefly Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Senhance Ultrasonic System
FDA 510(k)
FDA Class 2
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da Vinci Force Feedback Instruments
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
da Vinci Surgical System (IS5000)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
da Vinci SP Surgical System (SP1098)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Intuitive Surgical
| K Number | Device Name | ||
|---|---|---|---|
| K260695 | da Vinci Firefly Imaging System | May 22, 2026 | Substantially Equivalent |
| K241635 | da Vinci E-200 Electrosurgical Generator | Aug 5, 2024 | Substantially Equivalent |
| K241621 | Da Vinci Monopolar and Bipolar Adapters (378896) | Aug 2, 2024 | Substantially Equivalent |
| 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 |
| K191736 | da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 | Jul 26, 2019 | Substantially Equivalent |
| K182643 | IRIS 1.0 System | Feb 22, 2019 | Substantially Equivalent |
| K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | Feb 14, 2019 | Substantially Equivalent |