GENYX MEDICAL INJECTION NEEDLE— 510(k) K990996

Name: FDA 510(k) clearance K990996
Creator: U.S. Food and Drug Administration
Published: 1999-06-18

Substantially Equivalent

Genyx Medical, Inc.

FDA 510(k) clearance K990996 for GENYX MEDICAL INJECTION NEEDLE, Substantially Equivalent on 1999-06-18. Applicant: Genyx Medical, Inc.. Device class: 2.

Clearance details

Applicant: Genyx Medical, Inc.
Product code: Code FBK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1999-03-25
Decision date: 1999-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aliso Viejo, CA, US

Download summary PDF View on FDA.gov ↗

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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.