Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal— 510(k) K182259

Substantially Equivalent

Acell, Inc.

FDA 510(k) clearance K182259 for Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal, Substantially Equivalent on 2019-02-07. Applicant: Acell, Inc..

Clearance details

Applicant: Acell, Inc.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2018-08-21
Decision date: 2019-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

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.