Domain Surgical, Inc.
FDA Regulatory Profile
Domain Surgical, Inc. appears in FDA public data with 1 recall, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0690-2017, Class II) was initiated on October 24, 2016. Its most recent 510(k) clearance was granted on January 2, 2015.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0690-2017 | Class II | FMsealer Open Shears. Model FM3001 | October 24, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K142229 | Laparoscopic FMsealer | January 2, 2015 |
| K141484 | OPEN FMSEALER | July 30, 2014 |
| K140384 | FMWAND HANDPIECE SE | May 23, 2014 |
| K130606 | FMWAND FERROMAGNETIC SURGICAL SYSTEM | January 3, 2014 |
| K121881 | DOMAIN SURGICAL SYSTEM | October 18, 2012 |
| K110439 | DOMAIN SURGICAL SYSTEM | July 18, 2011 |