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

Clearance details

Applicant

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

Product code

Code GDW

Device class

Class 2

Regulation

21 CFR 878.4750

Advisory panel

General, Plastic Surgery

Date received

2014-09-12

Decision date

2015-06-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Beijing, CN

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• K202843 — Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)2021-01-12
• K202706 — Surgical Gown (Sterile), Surgical Gown (Non-sterile)2020-12-31
• K152618 — PANTHER Cutter Stapler2015-11-12
• K103470 — PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP2011-01-11

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 →