SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE
FDA 510(k) clearance K120215 · decided 2012-04-30
Clearance details
- K-number
- K120215
- Device name
- SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE
- Applicant
- Intuitive Surgical, Inc.
- Decision
- Unknown
- Date received
- 2012-01-24
- Decision date
- 2012-04-30
- Days to decision
- 97 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000); Model numb recall (Z-2751-2015) | Intuitive Surgical, Inc. | 2015-09-10 |
| Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428058- recall (Z-2754-2015) | Intuitive Surgical, Inc. | 2015-09-10 |
| Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 4280 recall (Z-2755-2015) | Intuitive Surgical, Inc. | 2015-09-10 |