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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)K171373Substantially equivalent (SESE) · 2017-10-10clearance family

Predicate lineage

Cited as predicate by: K210603, K210605

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
2026-06-24NAINo action indicated3m Company0
2026-06-24NAINo action indicated3m Company0
2019-04-17VAIVoluntary action indicated3M4
2017-11-27NAINo action indicated3M Company0
2016-12-08NAINo action indicated3M Company0
2016-12-08NAINo action indicated3M Company0
2016-12-06NAINo action indicated3M Company0
2016-09-14NAINo action indicated3M Company0
2015-11-06VAIVoluntary action indicated3M Company1
2015-03-19OAIOfficial action indicated3m Canada Company5
2014-07-09NAINo action indicated3M Co0
2014-07-09NAINo action indicated3M Co0
2014-06-26NAINo action indicated3M Company0
2014-06-26NAINo action indicated3M Company0
2014-04-25NAINo action indicated3M Company0
2013-12-13NAINo action indicated3M Company0
2013-08-16NAINo action indicated3m Company0
2013-08-16NAINo action indicated3m Company0
2013-03-28NAINo action indicated3M Company1
2012-12-05NAINo action indicated3M COMPANY0
2010-06-07WLWarning Letter3M Company—
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