ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS
FDA 510(k) clearance K140553 · decided 2014-07-25
Clearance details
- K-number
- K140553
- Device name
- ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS
- Applicant
- Intuitive Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-03-04
- Decision date
- 2014-07-25
- Days to decision
- 143 days
- Clearance type
- Traditional
- 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); da Vinci E-200 Generator (K253556) | Intuitive Surgical, Inc. | 2026-01-16 |
| da Vinci SP Surgical System (SP1098) (K252675) | Intuitive Surgical, Inc. | 2025-12-15 |
| da Vinci SP Surgical System (SP1098) (K252069) | Intuitive Surgical, Inc. | 2025-12-02 |
| da Vinci SP Surgical System (SP1098) (K251426) | Intuitive Surgical, Inc. | 2025-10-03 |
| da Vinci SP Surgical System (SP1098) (K251817) | Intuitive Surgical, Inc. | 2025-09-10 |
| da Vinci Surgical System (IS5000) (K251227) | Intuitive Surgical, Inc. | 2025-09-08 |
| da Vinci SP Surgical System (SP1098) (K251324) | Intuitive Surgical, Inc. | 2025-08-29 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical d recall (Z-2675-2016) | Intuitive Surgical, Inc. | 2016-08-26 |
| STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive Surgica recall (Z-2676-2016) | Intuitive Surgical, Inc. | 2016-08-26 |
| STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical d recall (Z-2348-2016) | Intuitive Surgical, Inc. | 2016-08-05 |
| SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; recall (Z-1837-2016) | Intuitive Surgical, Inc. | 2016-05-27 |