TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)— 510(k) K180030

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K180030 for TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large), Substantially Equivalent on 2018-04-24. Applicant: Medtronic, Inc..

Clearance details

Applicant: Medtronic, Inc.
Product code: Code FTL
Advisory panel: General, Plastic Surgery
Date received: 2018-01-03
Decision date: 2018-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

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.