K983200

Substantially Equivalent

INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX

Applicant: Ximed/Prosure/Injectx
Product code: GAA
Advisory panel: General, Plastic Surgery
Date received: 1998-09-14
Decision date: 1998-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

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.