Identifiers
- 510(k) Number
- K173323 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 AnastoClip GC Closure System is an implantable clip designed for vascular anastomosis, providing a secure and compliant closure of blood vessels. It is intended to facilitate vascular connections while accommodating pulsatile blood flow through its interrupted placement, allowing the anastomosis to contract and expand naturally.
This system is supplied as a sterile, single-use device and is classified under FDA 510(k) clearance as a Class II medical device. It is intended for use in surgical settings, particularly in general and plastic surgery procedures. The device exhibits MRI compatibility with an artifact extending approximately 4 mm when imaged using a gradient echo pulse sequence on a 3-Tesla MR system. Multiple sizes and configurations are available, as indicated by the associated registration numbers.
Frequently asked questions
What types of surgical procedures is the AnastoClip GC Closure System intended for, and how does it differ from traditional anastomosis methods?
The AnastoClip GC Closure System is designed for vascular anastomosis in surgical settings, particularly within general and plastic surgery. Unlike traditional continuous suture techniques, this device uses an interrupted clip placement to create a secure closure that accommodates pulsatile blood flow. This allows the anastomosis to naturally expand and contract with the vessel, potentially reducing stress on the suture line and improving long-term durability.
How many sizes and configurations are available for the AnastoClip GC Closure System, and how do I determine which one to use?
The AnastoClip GC Closure System comes in multiple sizes and configurations, as indicated by the listed registration numbers (e.g., 3021194552, 1018233, etc.). The appropriate size depends on the diameter and specific anatomical requirements of the vessel being sutured. Consult the manufacturer’s sizing guide or surgical planning tools to match the clip dimensions to the patient’s anatomy for optimal fit and closure.
Is the AnastoClip GC Closure System reusable, or is it intended for single-use only? How should it be stored if unused?
The AnastoClip GC Closure System is explicitly supplied as a sterile, single-use device. It is not designed for reuse or reprocessing. Unused devices should be stored in their original packaging, protected from moisture, extreme temperatures, and direct sunlight, following the manufacturer’s storage instructions to maintain sterility and integrity until use.
Can the AnastoClip GC Closure System be used in patients who require MRI scans, and what limitations should be considered?
Yes, the AnastoClip GC Closure System is MRI-compatible, but it produces an artifact measuring approximately 4 mm when imaged using a gradient echo pulse sequence on a 3-Tesla MR system. Clinicians should inform radiology staff about the device’s presence to avoid misinterpretation of imaging results and ensure proper scan planning to minimize artifact interference.
What regulatory pathway was followed for the FDA clearance of the AnastoClip GC Closure System, and how does this affect its use in clinical practice?
The AnastoClip GC Closure System received FDA 510(k) clearance under the Traditional 510(k) Review pathway, classified as a Class II medical device and substantially equivalent to a predicate device. This clearance confirms its safety and effectiveness for the intended use in vascular anastomosis, as determined by the FDA’s review of clinical data and manufacturing processes. Clinicians may rely on this clearance to ensure compliance with U.S. regulatory standards when incorporating the device into surgical procedures.
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: AnastoClip GC® Closure System | LeMaitre, AnastoClip GC® Closure System - LeMaitre, LeMaitre AnastoClip GC Instructions For Use Manual, Lemaitre AnastoClip GC Manuals | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173323 | Class II | Active |
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Manufacturer
- Manufacturer
- LeMaitre Vascular, Inc.
Sources (1)
- FDA 510(k) K173323 24 fields · synced Sep 20, 2026