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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances
  • 510(k)K193380Substantially equivalent (SESE) · 2020-07-20clearance family

Predicate lineage

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-05-02NAINo action indicatedCerenovus0
2016-09-30VAIVoluntary action indicatedCerenovus Inc1
2016-09-21VAIVoluntary action indicatedCerenovus, Inc.1
2016-09-21VAIVoluntary action indicatedCerenovus, Inc.1
2015-10-22NAINo action indicatedCerenovus Inc0
2015-10-22NAINo action indicatedCerenovus Inc0
2014-03-14VAIVoluntary action indicatedCerenovus Inc4
2013-11-05VAIVoluntary action indicatedCerenovus, Inc.6
2013-11-05VAIVoluntary action indicatedCerenovus, Inc.6
2011-09-27NAINo action indicatedCerenovus, Inc.0
2011-09-27NAINo action indicatedCerenovus, Inc.0
2011-03-04VAIVoluntary action indicatedCerenovus, Inc.1
2011-03-04VAIVoluntary action indicatedCerenovus, Inc.1
2010-12-30VAIVoluntary action indicatedCerenovus Inc7
2010-06-17NAINo action indicatedCerenovus, Inc.0
2010-06-17NAINo action indicatedCerenovus, Inc.0
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