PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP— 510(k) K103470

Substantially Equivalent

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

FDA 510(k) clearance K103470 for PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP, Substantially Equivalent on 2011-01-11. 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: 2010-11-26
Decision date: 2011-01-11
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.