CUSTOMED CYSTO PACK I— 510(k) K902274

Unknown

Customed, Inc.

FDA 510(k) clearance K902274 for CUSTOMED CYSTO PACK I, Unknown on 1990-09-20. Applicant: Customed, Inc..

Clearance details

Applicant: Customed, Inc.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 1990-05-21
Decision date: 1990-09-20
Decision: Unknown
Clearance type: Traditional
Location: Puerto Rico, US

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Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

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.