AUTOJECT 2 FOR GLASSY SYRINGE— 510(k) K122837

Substantially Equivalent

Owen Mumford, Ltd.

FDA 510(k) clearance K122837 for AUTOJECT 2 FOR GLASSY SYRINGE, Substantially Equivalent on 2012-10-15. Applicant: Owen Mumford, Ltd..

Clearance details

Applicant: Owen Mumford, Ltd.
Product code: Code KZH
Advisory panel: General Hospital
Date received: 2012-09-17
Decision date: 2012-10-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Woodstock, Oxfordshire, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code KZH

product code KZH

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.