Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm— 510(k) K202665

Clearance details

Applicant

Ethicon Endo-Surgery, LLC

Product code

Code GDW

Device class

Class 2

Regulation

21 CFR 878.4750

Advisory panel

General, Plastic Surgery

Date received

2020-09-14

Decision date

2020-10-15

Decision

Substantially Equivalent

Clearance type

Special

Location

Guaynabo, PR, US

• 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

• K252906 — ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)2026-01-09
• K241630 — ECHELON 4000 60mm Compact Stapler (EC3D60C) +6 more2024-10-28
• K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C) +5 more2024-07-03
• K232313 — LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420) +1 more2023-08-29
• K230387 — ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C) +4 more2023-04-13

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 →

• Z-2326-2021 — ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60AClass II·Terminated·Ethicon Endo-Surgery Inc·20210603

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K202665.