FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
8mm Monopolar Curved Scissors
K Number: K180033
·
Decision Apr 6, 2018
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
148
Applicant Total
9
Review Days
92
Basic Information
- Device Name
- 8mm Monopolar Curved Scissors
- K Number
- K180033
- 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
- January 4, 2018
- Decision Date
- April 6, 2018
- 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.
Vessel Sealer Curved (480522)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SP Endoscope, 0° (430600)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
da Vinci SP Surgical System (SP1098)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
da Vinci SP Advanced Access Port Kit (432701)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Intuitive Surgical, Inc
| K Number | Device Name | ||
|---|---|---|---|
| K232773 | da Vinci SP Surgical System (SP1098) | Jun 4, 2024 | Substantially Equivalent |
| K223080 | da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) | Nov 22, 2022 | Substantially Equivalent |
| K183086 | da Vinci X and Xi Surgical System | Mar 31, 2020 | Substantially Equivalent |
| K182140 | da Vinci Xi Surgical System, da Vinci X Surgical System | Oct 24, 2018 | Substantially Equivalent |
| K173842 | da Vinci Xi Surgical System, da Vinci X Surgical System | Apr 23, 2018 | Substantially Equivalent |
| K171632 | da Vinci Xi Surgical System | Sep 19, 2017 | Substantially Equivalent |
| K171699 | da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System | Jul 28, 2017 | Substantially Equivalent |
| K170713 | da Vinci Xi Surgical System | Jun 13, 2017 | Substantially Equivalent |