FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
da Vinci SP Surgical System (SP1098)
K Number: K211595
·
Decision Jun 23, 2021
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
148
Applicant Total
70
Review Days
30
Basic Information
- Device Name
- da Vinci SP Surgical System (SP1098)
- K Number
- K211595
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Intuitive Surgical, Inc.
- Date Received
- May 24, 2021
- Decision Date
- June 23, 2021
- 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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SP Endoscope, 0° (430600)
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Other Clearances by Intuitive Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251490 | 8 mm Assist Cannula; 12 mm Assist Cannula | Jul 2, 2025 | Substantially Equivalent |
| K250674 | Vessel Sealer Curved (480522) | Jun 13, 2025 | Substantially Equivalent |
| K240852 | da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) | Jun 11, 2025 | Substantially Equivalent |
| K250786 | SP Endoscope, 0° (430600) | May 13, 2025 | Substantially Equivalent |
| K243714 | da Vinci SP Surgical System (SP1098) | Apr 24, 2025 | Substantially Equivalent |
| K242427 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | Apr 1, 2025 | Substantially Equivalent |
| K243596 | da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | Mar 10, 2025 | Substantially Equivalent |
| K243582 | da Vinci SP Advanced Access Port Kit (432701) | Feb 28, 2025 | Substantially Equivalent |
| K243641 | da Vinci Surgical System (IS5000) | Dec 16, 2024 | Substantially Equivalent |
| K242318 | da Vinci SP Surgical System (SP1098) | Nov 26, 2024 | Unknown |