Ethicon Endo-Surgery, LLC · Class II · Cleared Feb 25, 2025
| K-number | K243276 |
| Device name | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler (GTX60); ECHELON LINEAR Stapler 90mm Stapler (GTX90); ECHELON LINEAR Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR Stapler 3D 90mm Green Reload (GTXR90G) |
| Applicant | Ethicon Endo-Surgery, LLC |
| Product code | GDW |
| Device class | Class II |
| Decision date | Feb 25, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4750 |
The ETHICON Linear Stapler is a sterile, single-use surgical device that delivers two staggered rows of titanium staples to approximate and transect internal tissues. It is used in open surgical procedures throughout the alimentary tract and thoracic surgery for tissue resection and anastomosis. The device is reloadable up to eight times per procedure and comes in 30mm, 60mm, and 90mm sizes with blue and green reload options.
The subject device uses 3D-formed staple geometry (versus 2D in the predicate), incorporates Gripping Surface Technology (GST) on the reload cartridge deck (versus flat surface), and uses titanium alloy Ti3Al2.5V wire staples (versus Ti-6Al-4V in the predicate). All other characteristics—two staggered staple rows, manual operation, maximum 8 firings, sterile single-use packaging, gamma sterilization, and SAL 10-6—are identical to the predicate.
ISO 10993-1 for biocompatibility evaluation. The submission references bench performance testing, animal in-vivo testing (acute hemostasis and tissue healing response), staple line strength testing, and human factors/usability testing, but does not cite specific ASTM, IEC, or other consensus standards by number.
The 3D staple geometry and GST reload technology are borrowed from other cleared Ethicon devices (ECHELON Endocutters and ECHELON Circular Powered Stapler). Bench and animal testing demonstrate that the subject device achieves substantially equivalent stapling performance (formed staple height, form quality, line integrity, and strength) to the predicate despite these design changes. The 90mm size, which has no direct 90mm predicate, is supported by design verification showing it operates on the same principles as the 30mm and 60mm devices and raises no new safety or effectiveness questions. The predicate device has not been subject to recalls related to these design modifications.
View the full FDA submission: accessdata.fda.gov