INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180
FDA 510(k) clearance K050005 · decided 2005-01-25
Clearance details
- K-number
- K050005
- Device name
- INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180
- Applicant
- Intuitive Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-01-03
- Decision date
- 2005-01-25
- Days to decision
- 22 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 |
|---|---|---|
| 8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuit recall (Z-1442-2013) | Intuitive Surgical, Inc. | 2013-05-31 |
| Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessor recall (Z-1425-2013) | Intuitive Surgical, Inc. | 2013-05-29 |