TSolution One w/ACG surgical System
FDA 510(k) clearance K150741 · decided 2015-10-22
Clearance details
- K-number
- K150741
- Device name
- TSolution One w/ACG surgical System
- Applicant
- THINK Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-03-23
- Decision date
- 2015-10-22
- Days to decision
- 213 days
- Clearance type
- Traditional
- Product code
- OJP
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Fremont, 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 |
|---|---|---|
| CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM (K140585) | Curexo Technology Corporation | 2014-08-18 |
| DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM (K140038) | Curexo Technology Corporation | 2014-05-27 |
| DIGIMATCH ROBODOC SURGICAL SYSTEM (K072629) | Integrated Surgical Systems, Inc. | 2008-08-06 |
Recalls involving this device
No recalls on record reference this clearance.