K903749

Substantially Equivalent

ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U

Applicant: Downs Surgical , Ltd.
Product code: GDM
Advisory panel: General, Plastic Surgery
Date received: 1990-08-16
Decision date: 1990-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sheffield S9 4wj, GB

Adverse events under product code GDM

product code GDM

Death: 2
Total: 2

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.