IntelliCartTM System
FDA 510(k) clearance K190789 · decided 2019-04-24
Clearance details
- K-number
- K190789
- Device name
- IntelliCartTM System
- Applicant
- Dornoch Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2019-03-27
- Decision date
- 2019-04-24
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- JCX
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Riverside, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.