THE ARTAS SYSTEM
FDA 510(k) clearance K123548 · decided 2013-02-25
Clearance details
- K-number
- K123548
- Device name
- THE ARTAS SYSTEM
- Applicant
- Restoration Robotics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-11-19
- Decision date
- 2013-02-25
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- ONA
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Josev, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ARTAS System (K173358) | Restoration Robotics, Inc. | 2018-03-16 |
| ARTAS SYSTEM FROM RESTORATION ROBOTICS (K123154) | Restoration Robotics, Inc. | 2013-02-19 |
| THE ARTAS SYSTEM FROM RESTORATION ROBOTICS (K103428) | Restoration Robotics, Inc. | 2011-04-04 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using G recall (Z-0353-2014) | Restoration Robotics | 2013-11-18 |
| ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP- recall (Z-0354-2014) | Restoration Robotics | 2013-11-18 |
| Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY recall (Z-0355-2014) | Restoration Robotics | 2013-11-18 |
| ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with V recall (Z-0356-2014) | Restoration Robotics | 2013-11-18 |