Gazelle Polypropylene Suture and Delivery Device— 510(k) K173644

Name: FDA 510(k) clearance K173644
Creator: U.S. Food and Drug Administration
Published: 2018-02-15

Substantially Equivalent

Dura Tap, LLC

FDA 510(k) clearance K173644 for Gazelle Polypropylene Suture and Delivery Device, Substantially Equivalent on 2018-02-15. Applicant: Dura Tap, LLC. Device class: 2.

Clearance details

Applicant: Dura Tap, LLC
Product code: Code GAW
Device class: Class 2
Regulation: 21 CFR 878.5010
Advisory panel: General, Plastic Surgery
Date received: 2017-11-27
Decision date: 2018-02-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Wayne, PA, US

Download summary PDF View on FDA.gov ↗

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K173335 — Gazelle PTFE and Suture Delivery Device2018-02-08

Adverse events under product code GAW

product code GAW

Death: 66
Injury: 1,616
Malfunction: 10,428
Total: 12,110

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.