K063136

Substantially Equivalent

NEEDLELESS SLING

Applicant: Specialities Remeex International, S.L.
Product code: PAH
Advisory panel: General, Plastic Surgery
Date received: 2006-10-16
Decision date: 2006-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Adverse events under product code PAH

product code PAH

Injury: 886
Malfunction: 529
Total: 1,415

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.