SANIFIX— 510(k) K883983

Substantially Equivalent for Some Indications

Iberhospitex, S.A.

FDA 510(k) clearance K883983 for SANIFIX, Substantially Equivalent for Some Indications on 1988-12-13. Applicant: Iberhospitex, S.A..

Clearance details

Applicant: Iberhospitex, S.A.
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1988-09-20
Decision date: 1988-12-13
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Barcelona, Spain, ES

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Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.