FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
8 mm Assist Cannula; 12 mm Assist Cannula
K Number: K251490
·
Decision Jul 2, 2025
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
1391
Applicant Total
70
Review Days
49
Basic Information
- Device Name
- 8 mm Assist Cannula; 12 mm Assist Cannula
- K Number
- K251490
- 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
- May 14, 2025
- Decision Date
- July 2, 2025
- Product Code
- GCJ
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Intuitive Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K241814 | da Vinci SP Instruments (SP1098) | Nov 18, 2024 | Unknown |