TMS-Cobot TS MV
FDA 510(k) clearance K182768 · decided 2019-02-17
Clearance details
- K-number
- K182768
- Device name
- TMS-Cobot TS MV
- Applicant
- Axilum Robotics
- Decision
- Substantially Equivalent
- Date received
- 2018-09-28
- Decision date
- 2019-02-17
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- QFF
- Device class
- 2
- Regulation number
- 882.5805
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Strasbourg, FR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Axilum Robotics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Zeta TMS Navigation System (K261471) | Zeta Surgical, Inc. | 2026-07-09 |
Recalls involving this device
No recalls on record reference this clearance.