Skip to content
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

    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
    2024-09-11NAINo action indicatedIntersurgical Inc0
    2024-09-11NAINo action indicatedIntersurgical Inc0
    2018-11-01NAINo action indicatedIntersurgical Inc0
    2018-11-01NAINo action indicatedIntersurgical Inc0
    2016-11-18VAIVoluntary action indicatedIntersurgical Inc0
    2016-11-18VAIVoluntary action indicatedIntersurgical Inc0
    2014-10-29VAIVoluntary action indicatedIntersurgical Inc3
    2014-10-29VAIVoluntary action indicatedIntersurgical Inc3
    2011-12-30WLWarning LetterIntersurgical, Ltd.—
    2011-12-30WLWarning LetterIntersurgical, Ltd.—
    2011-12-21VAIVoluntary action indicatedIntersurgical Inc1
    2011-12-21VAIVoluntary action indicatedIntersurgical Inc1
    2011-07-14OAIOfficial action indicatedIntersurgical, Ltd.0
    2011-07-14OAIOfficial action indicatedIntersurgical, Ltd.0
    Similar devices
    Select up to two to place side-by-side with this device.