Checkpoint Surgical Inc
FDA Regulatory Profile
Checkpoint Surgical Inc appears in FDA public data with 2 recalls, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1466-2025, Class II) was initiated on February 24, 2025. Its most recent 510(k) clearance was granted on August 26, 2021.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1466-2025 | Class II | Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperativ | February 24, 2025 |
| Z-1467-2025 | Class II | Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperativ | February 24, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K212355 | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large | August 26, 2021 |