Ligaclip 5 M/L Mm Endoscopic Multiple Clip Applier
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K050344 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 Ligaclip 5 M/L Mm Endoscopic Multiple Clip Applier is an implantable clip device designed to provide a means of ligation for tubular structures or vessels. It functions as an endoscopic instrument to facilitate the application of metal clips during surgical procedures.
This device is supplied as a sterile, single-patient-use instrument. It is intended for use through appropriately-sized trocars and features a shaft that can be rotated 360 degrees. The device is authorized under FDA 510(k) clearance.
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: LIGAMAX™ 5 Endoscopic Multiple Clip Applier | J&J MedTech US, LIGACLIP™ Endoscopic Rotating Multiple Clip Applier, EL5ML | Ethicon, Ligaclip 5 M/L Mm Endoscopic Multiple Clip Applier
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050344 | Class II | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, Inc.
- FDA Applicant
- Ethicon Endo Surgery, Inc.
Sources (1)
- FDA 510(k) K050344 24 fields · synced Sep 26, 2026