ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL— 510(k) K112056

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

2011-07-19

Decision date

2011-12-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cincinnati, OH, US

• K254291 — easyEndo E-Lite Single Use Powered Endoscopic Staplers +2 more2026-09-25
• 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

• K254196 — HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)2026-09-17
• K252906 — ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)2026-01-09
• K243276 — ECHELON LINEAR Stapler 30mm Stapler (GTX30) +8 more2025-02-25
• K241630 — ECHELON 4000 60mm Compact Stapler (EC3D60C) +6 more2024-10-28
• K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C) +5 more2024-07-03

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-1530-2013 — ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid. The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON 60 instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portion of the shaft to facilitate lateral access of the operative site. The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments'¿" lock-out feature is designed to prevent a used reload from being refired.Class II·Terminated·Ethicon Endo-Surgery Inc·20130513

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112056.