FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IS4000 da Vinci EndoWrist Instruments
K Number: K150284
·
Decision May 15, 2015
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
148
Applicant Total
73
Review Days
99
Basic Information
- Device Name
- IS4000 da Vinci EndoWrist Instruments
- K Number
- K150284
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- INTUITIVE SURGICAL, INC.
- Date Received
- February 5, 2015
- Decision Date
- May 15, 2015
- 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 |
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Other Clearances by INTUITIVE SURGICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K153276 | da Vinci Xi Surgical System | Aug 7, 2016 | Substantially Equivalent |
| K152578 | da Vinci Surgical System, Model IS4000 | Mar 30, 2016 | Substantially Equivalent |
| K152448 | da Vinci Single-Site Instrument and Accessories | Mar 9, 2016 | Substantially Equivalent |
| K152421 | IS4000 Stapler 30 Instrument and Stapler 30 Reloads | Mar 4, 2016 | Substantially Equivalent |
| K151450 | Endoscope Sterilization Tray | Jan 12, 2016 | Substantially Equivalent |
| K152663 | Bladeless Optical Obturators | Oct 16, 2015 | Substantially Equivalent |
| K150837 | IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps | Apr 29, 2015 | Substantially Equivalent |
| K143132 | IS4000 8mm Harmonic ACE Curved Shears | Apr 2, 2015 | Substantially Equivalent |
| K142937 | Endoscope Sterilization Tray | Feb 24, 2015 | Substantially Equivalent |
| K142683 | 12 mm Endoscopes and Accessories | Dec 10, 2014 | Substantially Equivalent |