Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads— 510(k) K201639

Clearance details

Applicant

Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

Product code

Code GDW

Device class

Class 2

Regulation

21 CFR 878.4750

Advisory panel

General, Plastic Surgery

Date received

2020-06-16

Decision date

2021-05-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Beijing, CN

• K260196 — ETHICON Circular Stapler (CDH21mm) +7 more2026-05-11
• K253657 — Tri-staple 2.0 Reloads +3 more2026-04-10
• K252739 — ETHICON 4000 45mm Compact Stapler (EC3DT45C) +6 more2025-12-17
• K250835 — ETHICON 4000 60mm Compact Stapler (EC3D60C) +6 more2025-05-14
• K243276 — ECHELON LINEAR Stapler 30mm Stapler (GTX30) +8 more2025-02-25

• K231513 — Oral Matrix2024-02-16
• K203622 — Medical Gloves2021-08-20
• K202844 — Medical Surgical Gowns2021-01-06
• K202029 — Medical Surgical Mask2020-12-16
• K201641 — Disposable Laparoscope Trocar2020-08-06

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 →