PANTHER Endo Linear Cutter Staplers with Single Use Loading Units— 510(k) K142577

Substantially Equivalent

B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.

FDA 510(k) clearance K142577 for PANTHER Endo Linear Cutter Staplers with Single Use Loading Units, Substantially Equivalent on 2015-06-11. Applicant: B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd..

Clearance details

Applicant: B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2014-09-12
Decision date: 2015-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

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.