Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230480 FDA 510(k)
- FDA Product Code
- FZP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4300 FDA 510(k)
- Regulation Number
- 878.4300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier is an automatic endoscopic applier. It is used for applying clips, specifically Weck Hem-o-lok Polymer Ligation Clips, during endoscopic procedures. The device is designed to provide secure occlusion and enhanced clip retention.
The Weck Auto Endo5 Applier is a single-use device, supplied with a 5mm diameter and 35cm length. It is classified as a class 2 device, with a product code of FZP and regulation number 878.4300. The device has been authorized with an FDA 510K clearance.
Frequently asked questions
What is the Weck Auto Endo5 Applier used for?
The Weck Auto Endo5 Applier is used for applying clips, specifically Weck Hem-o-lok Polymer Ligation Clips, during endoscopic procedures to provide secure occlusion and enhanced clip retention.
Is the Weck Auto Endo5 Applier a single-use device?
Yes, the Weck Auto Endo5 Applier is a single-use device, supplied with a 5mm diameter and 35cm length.
What is the regulatory status of the Weck Auto Endo5 Applier?
The Weck Auto Endo5 Applier has been authorized with an FDA 510K clearance, classified as a class 2 device with a product code of FZP and regulation number 878.4300.
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: Offizieller WECK Online Shop | Das Original seit 1900, PDF WECK® Auto Endo5® Automatic Clip Applier - Teleflex, WECK Einkochautomaten | Einwecktöpfe direkt vom Hersteller – WECK ..., AE05 Product Launch - Weck
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230480 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teleflex Medical
Sources (1)
- FDA 510(k) K230480 24 fields · synced Oct 1, 2026