DeviceSignal · 510(k) cleared
Cerenovus, Inc.
FDA 510(k) decision recorded 2026-08-14 · K262419 · Special 510(k)
Event510(k) cleared
Effective2026-08-14
DecisionSESE
On 2026-08-14 the FDA recorded a 510(k) clearance decision for Cerenovus, Inc., for MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME…. Clearance K262419. Product code HCG. A clearance is a regulatory decision, not an endorsement of the device.
Reported facts
- 510(k) number
- K262419
- Applicant
- Cerenovus, Inc.
- Device
- 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
- Decided on
- 2026-08-14
- Received on
- 2026-07-15
- Decision
- SESE
- Clearance type
- Special
- Product code
- HCG
- Review days
- 30
Every field above is as fda_device_510k published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_510k
- Source record
K262419- Snapshot hash
a17b676375c92ad46cfd0c81b2c18852150764f05c544c0889e193548d652e00- Source URL
- https://download.open.fda.gov/device/510k/device-510k-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_510k_to_clearance v1- Event rule
fda_device_510k_cleared v1- Event key
e3f8e1aae2d7c12fccd4f2f5ce1fbf0288925be1e857cf5b5b411a940c2d2f0e- Signal type
device_clearance.granted
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)