Endo Window High Frequency Electrocautery Device, Model EW018
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K021266 FDA 510(k)
- FDA Product Code
- KNS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.4300 FDA 510(k)
- Regulation Number
- 876.4300 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Endo Window High Frequency Electrocautery Device, Model Ew018, is a unit, electrosurgical, endoscopic device designed for bipolar electrosurgery. It delivers high-frequency electrical current to coagulate and cauterize tissue, forming a visible white coagulum through a rectangular window between its electrodes. This device is intended for use in endoscopic procedures, particularly within the gastroenterology and urology specialties.
This single-use, sterile, disposable device is fitted over flexible endoscopes with a maximum diameter of 8.7 mm. The electrodes are positioned distally on the exterior surface to ensure targeted tissue treatment. Regulated under FDA 510(k) clearance (K021266) with a classification of Class II, the device adheres to regulatory standards for endoscopic electrosurgical instruments. It is supplied as a sterile, ready-to-use item for one-time procedural application.
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: Endo Window High Frequency Electrocautery Device, Model Ew018, ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018 510 (k ..., www.accessdata.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K021266 | Class II | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, Inc.
Sources (1)
- FDA 510(k) K021266 24 fields · synced Sep 18, 2026