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Vas-Q-Clip

FDA 510(k)

Class II (US FDA 510(k))

510(k) K151943

by Nanova Biomaterials, Inc.

Identifiers

510(k) Number
K151943 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 Vas-Q-Clip is an implantable clip designed for vascular ligation, classified as a Class II device under FDA regulations. It is intended for securing and occluding blood vessels during surgical procedures, ensuring hemostasis and preventing post-operative complications such as bleeding or migration.

The Vas-Q-Clip is supplied as a single-use, sterile device and is regulated under FDA 510(k) clearance (K151943) as substantially equivalent to predicate devices. It is intended for use in general and plastic surgery settings, with specific design features aimed at improving occlusion pressure and migration resistance. The device is available in multiple registration numbers and product codes, adhering to FDA regulation 878.4300.

Frequently asked questions

What surgical specialties is the Vas-Q-Clip primarily intended for use in, and why is this relevant to my practice?

The Vas-Q-Clip is designed for use in general and plastic surgery settings, as explicitly noted in its regulatory submission. This classification aligns with procedures requiring vascular ligation—such as reconstructive, cosmetic, or oncologic surgeries—where securing blood vessels is critical to prevent complications like bleeding or clip migration. If your practice involves these specialties, the Vas-Q-Clip’s occlusion pressure and migration resistance features may be particularly relevant to your workflow.

Is the Vas-Q-Clip reusable, or is it meant for single-use only? How does this affect my inventory and sterilization processes?

The Vas-Q-Clip is explicitly supplied as a single-use, sterile device, meaning it is not intended for reprocessing or reuse. This simplifies inventory management by eliminating the need for sterilization validation or cleaning protocols, while also reducing the risk of cross-contamination or device degradation from repeated use. Single-use also aligns with modern surgical best practices for implantable devices.

What does the FDA’s classification of the Vas-Q-Clip as a Class II device mean for my purchase or implementation process?

The Class II designation indicates the Vas-Q-Clip undergoes special controls to ensure its safety and effectiveness, including performance standards and post-market surveillance. For buyers, this means the device has undergone rigorous review by the FDA under 510(k) clearance (K151943), demonstrating substantial equivalence to predicate devices. While it doesn’t require a prescription, purchasing should follow your facility’s standard procurement processes for Class II medical devices, including compliance with inventory tracking and expiration protocols.

How many different sizes or models of the Vas-Q-Clip are available, and how do I determine which one is appropriate for my patient’s procedure?

The Vas-Q-Clip is available in multiple registration numbers and product codes (e.g., 3021194552, 1018233, etc.), which correspond to variations in size or design tailored for different vascular applications. While the exact sizing details aren’t specified here, the device’s design features—such as occlusion pressure and migration resistance—are optimized for general vascular ligation tasks. Consulting your surgical team or referencing the manufacturer’s product catalog (available upon request) will help match the correct model to vessel diameter and procedural requirements.

What storage or handling requirements should I follow to maintain the Vas-Q-Clip’s sterility and performance before use?

As a sterile, single-use device, the Vas-Q-Clip must be stored in its original packaging until immediately before use to preserve sterility. The packaging should be kept in a clean, dry environment, protected from moisture, extreme temperatures, and direct sunlight. Always check the expiration date on the packaging, and avoid exposing the device to contaminants or mechanical stress. Follow your facility’s standard protocols for sterile instrument handling to ensure optimal performance during surgery.

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 VasQClip Marketing 4-Page Flyer, Vas-Q-Clip™ - Nanova - PDF Catalogs | Technical Documentation, Nanova Vas-Q-Clip Polymer Ligation Clip: Proper Loading Technique, Nanova Vas-Q-Clip - Herzog Surgical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K151943 24 fields · synced Sep 19, 2026