Gentrix Surgical Matrix— 510(k) K162554

Name: FDA 510(k) clearance K162554
Creator: U.S. Food and Drug Administration
Published: 2016-10-21

Substantially Equivalent

Acell, Inc.

FDA 510(k) clearance K162554 for Gentrix Surgical Matrix, Substantially Equivalent on 2016-10-21. Applicant: Acell, Inc.. Device class: 2.

Clearance details

Applicant: Acell, Inc.
Product code: Code FTM
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2016-09-13
Decision date: 2016-10-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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K191734 — MatriStem UBM Pericardial Patch2019-11-22
K192725 — Cytal Wound Matrix 3-Layer2019-10-25

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.