CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18— 510(k) K983610

Substantially Equivalent

Intersurgical, Inc.

FDA 510(k) clearance K983610 for CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18, Substantially Equivalent on 1999-04-30. Applicant: Intersurgical, Inc..

Clearance details

Applicant: Intersurgical, Inc.
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 1998-10-14
Decision date: 1999-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Liverpool, NY, US

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Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.