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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)K150779Substantially equivalent (SESE) · 2015-05-22clearance 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
2016-03-17VAIVoluntary action indicatedMicroAire Surgical Instruments, LLC3
2016-03-17VAIVoluntary action indicatedMicroAire Surgical Instruments, LLC3
2014-12-29WLWarning LetterMicroAire Surgical Instruments, LLC—
2014-12-29WLWarning LetterMicroAire Surgical Instruments, LLC—
2014-08-22OAIOfficial action indicatedMicroAire Surgical Instruments, LLC9
2014-08-22OAIOfficial action indicatedMicroAire Surgical Instruments, LLC9
2011-03-31VAIVoluntary action indicatedMicroAire Surgical Instruments, LLC4
2011-03-31VAIVoluntary action indicatedMicroAire Surgical Instruments, LLC4
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