FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
K Number: K243596
·
Decision Mar 10, 2025
Classifications
1
FEI Numbers
76
Registration Numbers
76
Same Product Code
41
Applicant Total
176
Review Days
109
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Basic Information
- Device Name
- da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
- K Number
- K243596
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intuitive Surgical, Inc.
- Date Received
- November 21, 2024
- Decision Date
- March 10, 2025
- Product Code
- GAG
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| GAG | Stapler, Surgical | FDA class 2 | General Hospital |
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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 |