FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
da Vinci Firefly Imaging System
K Number: K260695
·
Decision May 22, 2026
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
163
Applicant Total
17
Review Days
80
Basic Information
- Device Name
- da Vinci Firefly Imaging System
- K Number
- K260695
- 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 3, 2026
- Decision Date
- May 22, 2026
- 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 |
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Other Clearances by Intuitive Surgical
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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 |
| 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 |