Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear Cutter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K110385 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 Flex 45 / 60 Powered Articulating Endoscopic Linear Cutter is a surgical stapling device intended for transection, resection, and/or creation of anastomoses. It is designed for use in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. The device features articulating capabilities and is part of the Echelon family of endoscopic linear cutters.
The device is supplied as a single-use instrument and requires appropriate storage conditions. It has received FDA 510(k) clearance with the product code GDW and is classified as a Class II medical device. The device is intended for use in general and plastic surgery procedures, as indicated by its review advisory committee designation.
Frequently asked questions
What is the Echelon Flex 45/60 Powered Articulating Endoscopic Linear Cutter used for?
This device is a surgical stapling instrument designed for transection, resection, and creation of anastomoses in various open or minimally invasive surgical procedures including general, urologic, thoracic, and pediatric surgeries.
Is the Echelon Flex 45/60 single-use or reusable?
The Echelon Flex 45/60 is supplied as a single-use instrument, meaning it is designed for one surgical procedure only and should not be reused on another patient.
What are the storage requirements for this device?
The device requires appropriate storage conditions as specified by the manufacturer to maintain its integrity and functionality until use. Specific storage details would be provided in the product instructions for use.
What regulatory approvals does this device have?
The Echelon Flex 45/60 has received FDA 510(k) clearance with product code GDW and is classified as a Class II medical device. It is intended for use in general and plastic surgery procedures as indicated by its review advisory committee designation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ECHELON FLEX™ ENDOPATH™ Staplers | J&J MedTech US, Ethicon Endo-Surgery ECHELON FLEX 45 Instructions Manual, EC45A | Ethicon, Johnson & Johnson Ethicon Echelon Flex Instructions Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110385 | Class II | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, Inc.
Sources (1)
- FDA 510(k) K110385 24 fields · synced Sep 26, 2026