SIMPULSE SOLO SUCTION IRRIGATOR— 510(k) K942886

Substantially Equivalent

Davol Inc., Sub. C. R. Bard, Inc.

FDA 510(k) clearance K942886 for SIMPULSE SOLO SUCTION IRRIGATOR, Substantially Equivalent on 1994-07-19. Applicant: Davol Inc., Sub. C. R. Bard, Inc..

Clearance details

Applicant: Davol Inc., Sub. C. R. Bard, Inc.
Product code: Code FQH
Advisory panel: General Hospital
Date received: 1994-06-17
Decision date: 1994-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canston, RI, US

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Adverse events under product code FQH

product code FQH

Injury: 170
Malfunction: 2,513
Other: 1
Total: 2,684

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.