INJECTRA INJECTION NEEDLE— 510(k) K061222

Substantially Equivalent

Medi-Globe Corp.

FDA 510(k) clearance K061222 for INJECTRA INJECTION NEEDLE, Substantially Equivalent on 2006-07-03. Applicant: Medi-Globe Corp..

Clearance details

Applicant: Medi-Globe Corp.
Product code: Code FBK
Advisory panel: Gastroenterology, Urology
Date received: 2006-05-02
Decision date: 2006-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

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.