AceConnex Pre-Sutured Fascia— 510(k) K213046

Substantially Equivalent

Allosource

FDA 510(k) clearance K213046 for AceConnex Pre-Sutured Fascia, Substantially Equivalent on 2023-06-27. Applicant: Allosource.

Clearance details

Applicant: Allosource
Product code: Code GAT
Advisory panel: General, Plastic Surgery
Date received: 2021-09-22
Decision date: 2023-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Centennial, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

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.