Company ยท US
Cerenovus, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2023 to 2026. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (2 in 12 months)
1recalls (1 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 14, 2026 | K262419 | MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR1004 Cerenovus, Inc. | HCG |
| Aug 13, 2026 | K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set CERENOVUS, Inc. | NRY |
| Aug 22, 2025 | K251828 | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set Cerenovus, Inc. | NRY |
| Oct 16, 2024 | K241244 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter Cerenovus, Inc. | QJP |
| Oct 16, 2024 | K241221 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set Cerenovus, Inc. | NRY |
| May 9, 2024 | K233982 | CEREGLIDE 92 Catheter System Cerenovus, Inc. | QJP |
| Jan 17, 2024 | K233988 | Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set Cerenovus, Inc. | NRY |
| Nov 29, 2023 | K230726 | CEREGLIDE 92 Intermediate Catheter Cerenovus, Inc. | QJP |
| Mar 9, 2023 | K221934 | CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set Cerenovus, Inc. | NRY |
| Mar 9, 2023 | K221930 | CEREGLIDE 71 Intermediate Catheter Cerenovus, Inc. | QJP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2025 | Cerenovus Inc CEREPAK Detachable Coil System - Name/REF:
UNIFORM 2MM X 2.5 CM/FCX100202,
UNIFORM 2.5MM X 3.3 CM/FCX100253,
UNIFORM 3MM X 5.4 CM/FCX100305,
UNIFORM 3.5MM X 6.6 CM/FCX100356,
UNIFORM 4MM X 7.5 CM/FCX1 Open, Classified |
HCG | K220040 |