← Back to catalogue

Gillinov-Cosgrove LAA Clip

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131107

by Atricure, Inc.

Identifiers

510(k) Number
K131107 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 Gillinov-Cosgrove LAA Clip is an implantable device designed for the exclusion of the left atrial appendage (LAA). Classified as a clip, implantable device, it is intended for use in surgical procedures to occlude the LAA, reducing the risk of thrombus formation and stroke associated with atrial fibrillation. The device is engineered to provide both anatomical exclusion and electrical isolation of the LAA, as demonstrated in preclinical studies.

This device is supplied as a single-use, sterile implant intended for use in open surgical procedures. It is regulated under FDA 510(k) clearance (K131107) and falls under product code FZP, classified as a Class II medical device. The Gillinov-Cosgrove LAA Clip is delivered preloaded within the AtriClip LAA Exclusion System and requires sterile handling and surgical implantation. Multiple registration numbers (e.g., 3021194552) are associated with its regulatory filing.

Frequently asked questions

What is the Gillinov-Cosgrove LAA Clip used for?

The Gillinov-Cosgrove LAA Clip is designed to occlude the left atrial appendage (LAA) during open surgical procedures. By physically excluding the LAA, it aims to reduce the risk of thrombus formation and stroke in patients with atrial fibrillation. The device also provides electrical isolation of the LAA, as demonstrated in preclinical studies.

How is the Gillinov-Cosgrove LAA Clip supplied and prepared for use?

The device is supplied as a single-use, sterile implant preloaded within the AtriClip LAA Exclusion System. It requires sterile handling and is intended exclusively for surgical implantation. The preloaded system ensures readiness for use during open surgical procedures, minimizing additional preparation steps.

Is the Gillinov-Cosgrove LAA Clip reusable or intended for single-use?

The Gillinov-Cosgrove LAA Clip is explicitly designed for single-use only. This ensures patient safety by preventing cross-contamination and maintaining sterility, which is critical for an implantable device used in cardiac procedures.

What regulatory approvals does the Gillinov-Cosgrove LAA Clip hold?

The device holds FDA 510(k) clearance under the reference number K131107, classified as a Class II medical device under product code FZP. This clearance confirms its substantial equivalence to a predicate device and compliance with U.S. regulatory standards for surgical occlusion implants.

How should the Gillinov-Cosgrove LAA Clip be stored before use?

The device must be stored in its original, sterile packaging until ready for use. Proper storage conditions—protected from moisture, extreme temperatures, and physical damage—are essential to preserve sterility and functionality. Always follow the manufacturer’s instructions for storage to ensure the device remains effective for its intended single-use 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: PDF AtriClip® LAA Exclusion System with Preloaded Gillinov-Cosgrove® Clip, PDF P000727 rev G - AtriCure, Inc., AtriClip LAA Exclusion System with Gillinov-Cosgrove Clip ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Atricure, Inc.

Sources (1)

  • FDA 510(k) K131107 24 fields · synced Oct 1, 2026