GENYX FLEXIBLE INJECTION NEEEDLE— 510(k) K001146

Substantially Equivalent

Geny Medical, Inc.

FDA 510(k) clearance K001146 for GENYX FLEXIBLE INJECTION NEEEDLE, Substantially Equivalent on 2000-06-30. Applicant: Geny Medical, Inc..

Clearance details

Applicant: Geny Medical, Inc.
Product code: Code FBK
Advisory panel: Gastroenterology, Urology
Date received: 2000-04-10
Decision date: 2000-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aliso Viejo, CA, US

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Adverse events under product code FBK

product code FBK

Other: 1
Total: 1

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.