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.
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
- 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.