K952610

Substantially Equivalent

PLEXUS/3000 (P/3000), PLEXUS/3500 (P/3500)

Applicant: Plexus Medical
Product code: FNM
Advisory panel: General Hospital
Date received: 1995-06-07
Decision date: 1995-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendora, CA, US

Adverse events under product code FNM

product code FNM

Death: 22
Injury: 349
Other: 4
Total: 375

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.