Echelon 60 Endoscpic Linear Cutter Reload, White

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121600

Identifiers

510(k) Number: K121600 FDA 510(k)
FDA Product Code: GDW FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4750 FDA 510(k)
Regulation Number: 878.4750 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The ECHELON 60 Endoscopic Linear Cutter Reload, White device has been substantively equivalent to a staple implantable surgical product in the United States, as determined by an advisory committee review. This device is classified under medical devices classification code 878.4750 and has been cleared for traditional use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K121600	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Ethicon Endo-Surgery, LLC

Sources (1)

FDA 510(k) K121600 24 fields · synced Jul 20, 2026