Cerenovus Inc
FDA Regulatory Profile
Cerenovus Inc appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 8 510(k) clearances, 11 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0434-2026, Class I) was initiated on October 2, 2025. Its most recent 510(k) clearance was granted on August 22, 2025.
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 8
- Inspections
- 11
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0434-2026 | Class I | CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FC | October 2, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251828 | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set | August 22, 2025 |
| K241244 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter | October 16, 2024 |
| K241221 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing | October 16, 2024 |
| K233982 | CEREGLIDE 92 Catheter System | May 9, 2024 |
| K233988 | Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set | January 17, 2024 |
| K230726 | CEREGLIDE 92 Intermediate Catheter | November 29, 2023 |
| K221930 | CEREGLIDE 71 Intermediate Catheter | March 9, 2023 |
| K221934 | CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set | March 9, 2023 |