Cerenovus, Inc.: FDA clearances and approvals
Cerenovus, Inc. has 10 FDA 510(k) clearances (first 2023, latest 2026), plus 1 PMA decision, across 4 product codes in 1 review panel. Median 510(k) review time: 155 days. Since 2017 its median was 155 days, against 132 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Cerenovus, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 3 | 251 |
| 2024 | 4 | 155 |
| 2025 | 1 | 70 |
| 2026 | 2 | 30 |
Review time against the same product codes
Since 2017, Cerenovus, Inc.'s cleared 510(k)s took a median 155 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NRY | Catheter, Thrombus Retriever | 5 | 5 |
| QJP | Catheter, Percutaneous, Neurovasculature | 4 | 4 |
| HCG | Device, Neurovascular Embolization | 1 | 1 |
| KGG | Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations | 1 | 0 |
Review panels
- Neurology (11)
Most recent Cerenovus, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262419 | MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF | HCG | 2026-08-14 | 30 |
| K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set | NRY | 2026-08-13 | 30 |
| K251828 | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set | NRY | 2025-08-22 | 70 |
| K241244 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter | QJP | 2024-10-16 | 167 |
| K241221 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set | NRY | 2024-10-16 | 168 |
| K233982 | CEREGLIDE 92 Catheter System | QJP | 2024-05-09 | 143 |
| K233988 | Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set | NRY | 2024-01-17 | 30 |
| K230726 | CEREGLIDE 92 Intermediate Catheter | QJP | 2023-11-29 | 258 |
| K221934 | CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set | NRY | 2023-03-09 | 251 |
| K221930 | CEREGLIDE 71 Intermediate Catheter | QJP | 2023-03-09 | 251 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P990040 | PMA | TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM | 2000-09-25 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2025-10-02.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Cerenovus, Inc. have?
Cerenovus, Inc. has 10 FDA 510(k) clearances (first 2023, latest 2026), plus 1 PMA decision, across 4 product codes in 1 review panel.
How long does FDA take to clear Cerenovus, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cerenovus, Inc.'s cleared 510(k)s is 155 days. Since 2017: 155 days, versus 132 days for all cleared 510(k)s in the same product codes.
What devices does Cerenovus, Inc. make?
Its most frequent FDA product codes are NRY (Catheter, Thrombus Retriever, 5); QJP (Catheter, Percutaneous, Neurovasculature, 4); HCG (Device, Neurovascular Embolization, 1).
Has Cerenovus, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Cerenovus, Inc; the most recent began 2025-10-02. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 10 Cerenovus, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NRY, Cerenovus, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.