K951231

Substantially Equivalent

ORTHOPEDIC PACKS

Applicant: Sterile Concepts, Inc.
Product code: GAN
Advisory panel: General, Plastic Surgery
Date received: 1995-03-20
Decision date: 1995-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, VA, US

Adverse events under product code GAN

product code GAN

Injury: 599
Malfunction: 1,658
Total: 2,257

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.