FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
da Vinci SP Surgical System (SP1098)
K Number: K251324
·
Decision Aug 29, 2025
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
163
Applicant Total
176
Review Days
122
Basic Information
- Device Name
- da Vinci SP Surgical System (SP1098)
- K Number
- K251324
- 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, Inc.
- Date Received
- April 29, 2025
- Decision Date
- August 29, 2025
- 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.
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da Vinci Surgical System (IS5000)
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da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator
FDA 510(k)
FDA Class 2
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da Vinci SP Surgical System (SP1098)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Intuitive Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253986 | da Vinci Force Feedback Instruments | Mar 11, 2026 | Substantially Equivalent |
| K253978 | Universal Seal (5-12 mm) | Feb 24, 2026 | Substantially Equivalent |
| K251739 | da Vinci Surgical System (IS5000) | Jan 16, 2026 | Substantially Equivalent |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | Jan 16, 2026 | Substantially Equivalent |
| K251763 | IRISeg | Dec 16, 2025 | Substantially Equivalent |
| K252675 | da Vinci SP Surgical System (SP1098) | Dec 15, 2025 | Substantially Equivalent |
| K252069 | da Vinci SP Surgical System (SP1098) | Dec 2, 2025 | Substantially Equivalent |
| K251426 | da Vinci SP Surgical System (SP1098) | Oct 3, 2025 | Substantially Equivalent |
| K252045 | Ion Endoluminal System (IF1000) | Sep 23, 2025 | Substantially Equivalent |
| K251817 | da Vinci SP Surgical System (SP1098) | Sep 10, 2025 | Substantially Equivalent |