HEMO SUC NUMBER HS100-HS205— 510(k) K881036

Substantially Equivalent

Instrumental Medico Croquevielle S.A.

FDA 510(k) clearance K881036 for HEMO SUC NUMBER HS100-HS205, Substantially Equivalent on 1988-06-20. Applicant: Instrumental Medico Croquevielle S.A..

Clearance details

Applicant: Instrumental Medico Croquevielle S.A.
Product code: Code GCY
Advisory panel: General, Plastic Surgery
Date received: 1988-03-10
Decision date: 1988-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santiago, Chile, CL

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Adverse events under product code GCY

product code GCY

Malfunction: 786
Other: 1
Total: 787

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.