510(k) K181774— Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture

Substantially Equivalent

Teleflex Medical Incorporated

Clearance details

Applicant: Teleflex Medical Incorporated
Product code: Code GAT
Advisory panel: General, Plastic Surgery
Date received: 2018-07-03
Decision date: 2018-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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.