FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CorPath GRX System
K Number: K160121
·
Decision Oct 27, 2016
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
32
Applicant Total
9
Review Days
282
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CorPath GRX System
- K Number
- K160121
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1290
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corindus, Inc.
- Date Received
- January 19, 2016
- Decision Date
- October 27, 2016
- Product Code
- DXX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXX | System, Catheter Control, Steerable | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXX), ordered by most recent decision date.
Stereotaxis GenesisX RMN with Navigant Workstation (NWS)
FDA 510(k)
FDA Class 2
·Cardiovascular
LIBERTY Endovascular Robotic System (LIBERTYOS)
FDA 510(k)
FDA Class 2
·Cardiovascular
CorPath GRX System
FDA 510(k)
FDA Class 2
·Cardiovascular
CorPath GRX System
FDA 510(k)
FDA Class 2
·Cardiovascular
CorPath GRX System
FDA 510(k)
FDA Class 2
·Cardiovascular
CorPath GRX System
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Corindus, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K221464 | CorPath GRX System | Jul 27, 2022 | Substantially Equivalent |
| K202275 | CorPath GRX System | Dec 11, 2020 | Substantially Equivalent |
| K180517 | CorPath GRX System | Mar 29, 2018 | Substantially Equivalent |
| K173806 | CorPath GRX System | Mar 1, 2018 | Substantially Equivalent |
| K173288 | CorPath GRX System | Feb 15, 2018 | Substantially Equivalent |
| K152999 | CorPath 200 System | Mar 18, 2016 | Substantially Equivalent |
| K150892 | CorPath 200 System | Oct 2, 2015 | Substantially Equivalent |
| K120834 | CORPATH 200 SYSTEM | Jul 19, 2012 | Substantially Equivalent |