Custom Assemblies Inc
FDA Regulatory Profile
Custom Assemblies Inc appears in FDA public data with 1 recall, 1 510(k) clearance, 6 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-3059-2017, Class II) was initiated on June 15, 2017. Its most recent 510(k) clearance was granted on January 4, 2000.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 6
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3059-2017 | Class II | Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R | June 15, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K993463 | INTRAVASCULAR ADMINISTRATION SET | January 4, 2000 |