IS4000 da Vinci EndoWrist Instruments
FDA 510(k) clearance K150284 · decided 2015-05-15
Clearance details
- K-number
- K150284
- Device name
- IS4000 da Vinci EndoWrist Instruments
- Applicant
- Intuitive Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-02-05
- Decision date
- 2015-05-15
- Days to decision
- 99 days
- Clearance type
- Special
- Product code
- NAY
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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| da Vinci SP Surgical System (SP1098) (K252069) | Intuitive Surgical, Inc. | 2025-12-02 |
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| da Vinci SP Surgical System (SP1098) (K251817) | Intuitive Surgical, Inc. | 2025-09-10 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 8MM, ROUND TIP SCISSORS, IS4000 REF 470007 recall (Z-0850-2025) | Intuitive Surgical, Inc. | 2025-01-10 |
| 8MM,DEBAKEY FORCEPS,IS4000 REF 470036 recall (Z-0852-2025) | Intuitive Surgical, Inc. | 2025-01-10 |
| 8MM,CADIERE FORCEPS,IS4000 REF 470049 recall (Z-0853-2025) | Intuitive Surgical, Inc. | 2025-01-10 |
| 8MM,MEGA NEEDLE DRIVER,IS4000 REF 470194 recall (Z-0858-2025) | Intuitive Surgical, Inc. | 2025-01-10 |
| 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 470296 recall (Z-0864-2025) | Intuitive Surgical, Inc. | 2025-01-10 |
| 8MM,CADIERE FORCEPS,IS4000 REF 471049 recall (Z-0873-2025) | Intuitive Surgical, Inc. | 2025-01-10 |
| 8MM,COBRA GRASPER,IS4000 REF 471190 recall (Z-0877-2025) | Intuitive Surgical, Inc. | 2025-01-10 |
| 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296 recall (Z-0879-2025) | Intuitive Surgical, Inc. | 2025-01-10 |