510(k) K162965— SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction

Substantially Equivalent

Tei Biosciences, Inc.

Clearance details

Applicant: Tei Biosciences, Inc.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2016-10-24
Decision date: 2017-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

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.