MICRUSFRAME (19+ models)— 510(k) K262419
Substantially EquivalentCerenovus, Inc.
FDA 510(k) clearance K262419 for MICRUSFRAME (19+ models), Substantially Equivalent on 2026-08-14. Applicant: Cerenovus, Inc.. Device class: 2.
Summary
Cerenovus filed MICRUSFRAME under product code HCG, neurovascular embolization devices. The device name lists a long run of model numbers (MFR100202, MFR100253, and more) and is cut off in the record.
Class II, 21 CFR 882.5950. Neurology is both the classification panel and the review panel. It came in as a Special 510(k).
Cerenovus filed from Irvine, California. The decision came 30 calendar days after FDA received it (July 15 to August 14, 2026), and it was substantially equivalent.
Clearance details
- Device name as filed
- 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
- Applicant
- Cerenovus, Inc.
- Product code
- Product code HCG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
Recent devices under product code HCG
view allMore clearances from Cerenovus, Inc.
view all- K262398 — CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set
- K251828 — CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set
- K241221 — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set
- K241244 — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter
- K233982 — CEREGLIDE 92 Catheter System
Adverse events under product code HCG
product code HCG- Death
- 50
- Injury
- 801
- Malfunction
- 5,625
- Total
- 6,476
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.