Echelon Flex 45 Powered Articulating Endoscopic Linear Cutter +1 more model

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130653

Identifiers

510(k) Number: K130653 FDA 510(k)
FDA Product Code: GDW FDA 510(k)
Models / Variants: Echelon Flex 45 Powered Articulating Endoscopic Linear Cutter FDA 510(k)
Echelon Flex 60 Powered Articulating Endoscopic Linear Cu 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)

Echelon Flex 45 Powered Articulating Endoscopic Linear Cutter +1 more model by Ethicon Endo-Surgery, LLC — Class II — FDA_510K — listed in FDA 510(k) — 2 models

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	K130653	Class II	Active

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Manufacturer

Manufacturer: Ethicon Endo-Surgery, LLC

Sources (1)

FDA 510(k) K130653 24 fields · synced Jun 18, 2026