Ligaclip 20/20 Multiple Clip Applier

• 3 recalls, same reason

  • Terminated Z-1775-2013 FDA Class II ·initiated 12 Apr 2013 ·on shared 510(k) K864102
  • Terminated Z-1776-2013 FDA Class II ·initiated 12 Apr 2013 ·on shared 510(k) K864102
  • Terminated Z-1777-2013 FDA Class II ·initiated 12 Apr 2013 ·on shared 510(k) K864102

  Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure

• • Terminated Z-1055-04 FDA Unclassified (pre-2012) ·initiated 7 Jun 2004 ·on shared 510(k) K864102

  This device is subject to recall due to an increased possibility of clip scissoring which can result in less than optimal clip formation which may or may not securely ligate tubular structures.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K864102 ↗

FDA Product Code

FZP

FDA applicant

ETHICON, Inc.

Device Class

Class II

Regulation

21 CFR Part 878.4300

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What is the Ligaclip 20/20 Multiple Clip Applier primarily used for in surgical procedures?

  The Ligaclip 20/20 Multiple Clip Applier is designed specifically for vessel ligation, which means it securely occludes blood vessels during surgery to prevent bleeding while preserving tissue integrity. It is suitable for use in both open surgical procedures and endoscopic (minimally invasive) settings.

• How many clips does the Ligaclip 20/20 come preloaded with, and is it reusable?

  The Ligaclip 20/20 is preloaded with 20 titanium clips and is explicitly designed for single-use only. This ensures sterility and safety per regulatory standards, as reuse is not recommended or supported by the manufacturer.

• What types of surgical settings is this device compatible with, and how is it supplied?

  The Ligaclip 20/20 is compatible with both open surgical procedures and endoscopic (laparoscopic) surgeries. It is supplied sterile, preloaded with clips, and intended for one-time patient use to maintain sterility and compliance with regulatory requirements.

• What regulatory pathway does the Ligaclip 20/20 follow, and what does that mean for its use?

  The Ligaclip 20/20 received FDA 510(k) clearance (K864102), meaning it was determined to be substantially equivalent to a prior-generation device already on the market. This clearance confirms its compliance with U.S. regulatory standards for safety and effectiveness as a Clip, Implantable under FDA nomenclature, ensuring it meets established performance criteria for vessel ligation.