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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)K172405Substantially equivalent (SESE) · 2017-12-11clearance 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
2019-12-11VAIVoluntary action indicatedTrilliant Surgical, LLC5
2019-12-11VAIVoluntary action indicatedTrilliant Surgical, LLC5
2018-05-02VAIVoluntary action indicatedTrilliant Surgical, LLC10
2018-05-02VAIVoluntary action indicatedTrilliant Surgical, LLC10
2016-06-27OAIOfficial action indicatedTrilliant Surgical, LLC9
2016-06-27OAIOfficial action indicatedTrilliant Surgical, LLC9
2015-02-12OAIOfficial action indicatedTrilliant Surgical, LLC5
2015-02-12OAIOfficial action indicatedTrilliant Surgical, LLC5
2011-09-09VAIVoluntary action indicatedTrilliant Surgical, LLC3
2011-09-09VAIVoluntary action indicatedTrilliant Surgical, LLC3
2010-05-03WLWarning LetterTrilliant Surgical, LLC—
2010-05-03WLWarning LetterTrilliant Surgical, LLC—
2010-01-20OAIOfficial action indicatedTrilliant Surgical, LLC4
2010-01-20OAIOfficial action indicatedTrilliant Surgical, LLC4
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