Disposable Circular Stapler— 510(k) K172561

Clearance details

Applicant

Changzhou Kangdi Medical Stapler Co., Ltd.

Product code

Code GDW

Device class

Class 2

Regulation

21 CFR 878.4750

Advisory panel

General, Plastic Surgery

Date received

2017-08-25

Decision date

2017-12-05

Decision

Substantially Equivalent

Clearance type

Special

Location

Changzhou City, 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

• K172538 — Disposable Linear Stapler, Disposable Linear Cutter2017-11-30
• K121474 — DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER2012-07-16
• K100723 — DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.52010-04-30

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 →