Soma Access Systems LLC
FDA Regulatory Profile
Soma Access Systems LLC appears in FDA public data with 1 recall, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0215-2015, Class II) was initiated on March 24, 2014. Its most recent 510(k) clearance was granted on December 29, 2011.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0215-2015 | Class II | AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 2 | March 24, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K113680 | SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT | December 29, 2011 |