Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch— 510(k) K192490

Substantially Equivalent

Teleflex Medical

FDA 510(k) clearance K192490 for Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch, Substantially Equivalent on 2020-03-30. Applicant: Teleflex Medical.

Clearance details

Applicant: Teleflex Medical
Product code: Code GAT
Advisory panel: General, Plastic Surgery
Date received: 2019-09-11
Decision date: 2020-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

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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.