K152795

Substantially Equivalent

RiverLon (Nylon) Suture

Applicant: Riverpoint Medical
Product code: GAR
Advisory panel: General, Plastic Surgery
Date received: 2015-09-28
Decision date: 2015-10-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Portland, OR, US

Adverse events under product code GAR

product code GAR

Injury: 422
Malfunction: 3,386
Other: 4
Total: 3,812

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.