LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS— 510(k) K141367

Name: FDA 510(k) clearance K141367
Creator: U.S. Food and Drug Administration
Published: 2014-07-25

Substantially Equivalent

Touchstone International Medical Science Co., Ltd.

FDA 510(k) clearance K141367 for LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS, Substantially Equivalent on 2014-07-25. Applicant: Touchstone International Medical Science Co., Ltd.. Device class: 2.

Clearance details

Applicant: Touchstone International Medical Science Co., Ltd.
Product code: Code GDW
Device class: Class 2
Regulation: 21 CFR 878.4750
Advisory panel: General, Plastic Surgery
Date received: 2014-05-23
Decision date: 2014-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, Jiangsu, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.