CorPath GRX System
FDA 510(k) clearance K180517 · decided 2018-03-29
Clearance details
- K-number
- K180517
- Device name
- CorPath GRX System
- Applicant
- Corindus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-02-27
- Decision date
- 2018-03-29
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DXX
- Device class
- 2
- Regulation number
- 870.1290
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Corindus
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 |
|---|---|---|
| Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) (K251792) | Stereotaxis, Inc. | 2025-11-06 |
| LIBERTY Endovascular Robotic System (LIBERTYOS) (K243789) | Microbot Medical , Ltd. | 2025-09-04 |
| CorPath GRX System (K221464) | Corindus, Inc. | 2022-07-27 |
| CorPath GRX System (K202275) | Corindus, Inc. | 2020-12-11 |
| CorPath GRX System (K173806) | Corindus, Inc. | 2018-03-01 |
| CorPath GRX System (K173288) | Corindus, Inc. | 2018-02-15 |
| CorPath GRX System (K160121) | Corindus, Inc. | 2016-10-27 |
| CorPath 200 System (K152999) | Corindus, Inc. | 2016-03-18 |
| CorPath 200 System (K150892) | Corindus, Inc. | 2015-10-02 |
| Magellan Robotic System (K151730) | Hansen Medical, Inc. | 2015-07-23 |
| Magellan Robotic System, Magellan Robotic Catheter 10Fr (K143227) | Hansen Medical, Inc. | 2015-07-01 |
| Vdrive system, Vdrive Duo, Vdrive with V-Sono (K150312) | Stereotaxis, Inc. | 2015-06-17 |
Recalls involving this device
No recalls on record reference this clearance.