LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420) +1 more model

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K232313

Identifiers

510(k) Number: K232313 FDA 510(k)
FDA Product Code: FZP FDA 510(k)
Models / Variants: LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420) FDA 510(k)EUDAMED
LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) FDA 510(k)EUDAMED

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 Endoscopic Rotating Multiple Clip Applier is a surgical device classified as a Clip, Implantable, designed for endoscopic ligation of tubular structures or vessels. It delivers titanium clips to securely occlude tissue, facilitating precise control during minimally invasive procedures. The device is engineered for use in general and plastic surgery applications, ensuring secure closure of anatomical structures within the specified size range.

This single-use, sterile instrument is intended for endoscopic access through appropriately sized trocars. Each model (ER420 for 12mm and ER320 for 10mm) is pre-loaded with 20 titanium clips and is approved under FDA 510K and MDR regulations. The device is non-reusable and must be stored under sterile conditions prior to use. No MRI safety information is provided, and compliance with regulatory standards ensures safe clinical 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: LIGACLIP™ Endoscopic Rotating Multiple Clip Applier, LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420 ..., ER420-EMEA | Ethicon EMEA

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K232313	Class II	Active

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Manufacturer

Manufacturer: Ethicon Endo-Surgery, LLC
FDA Applicant: Ethicon Endo Surgery, LLC

Sources (2)

FDA 510(k) K232313 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 19, 2026