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AngioCCLUDE Ligating Clips

by A2 Medical Systems, LLC 510(k)

Active United States

510(k) K230966

Overview

The angiOCCLUDE Ligating Clips are implantable clips designed for vascular occlusion, classified as a Clip, Implantable under FDA product code FZP. These devices are intended to securely ligate blood vessels during surgical procedures, preventing blood flow and facilitating tissue separation or removal.

Used in general and plastic surgery settings, these clips are supplied sterile and intended for single-use. They are manufactured in multiple sizes and are regulated under FDA 510(k) clearance (K230966) as a Class 2 device. Storage and handling must adhere to sterile medical device protocols to ensure proper functionality and patient safety.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK230966 Date19 Sep 2023ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FZP
Device Class
Class II
Regulation
21 CFR Part 878.4300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from A2 Medical Systems, LLC

Questions

  • What types of surgical procedures are the angiOCCLUDE Ligating Clips primarily used for?

    The angiOCCLUDE Ligating Clips are designed for vascular occlusion during surgical procedures in general and plastic surgery settings. They are intended to securely ligate blood vessels, stopping blood flow to facilitate tissue separation or removal, such as during vascular surgeries or excisions.

  • Are the angiOCCLUDE Ligating Clips reusable or intended for single-use only?

    The angiOCCLUDE Ligating Clips are explicitly intended for single-use only. This ensures patient safety and maintains the device’s sterility and functionality, as reuse could compromise these critical factors.

  • How are the angiOCCLUDE Ligating Clips supplied, and what should I consider for storage?

    The clips are supplied sterile, meaning they are pre-packaged and ready for immediate surgical use without additional sterilization. Storage must follow sterile medical device protocols to preserve their integrity and prevent contamination, as improper handling could affect their performance.

  • What sizes or models of angiOCCLUDE Ligating Clips are available?

    The angiOCCLUDE Ligating Clips come in multiple sizes, as indicated by the extensive list of registration numbers (e.g., 3003495548, 1018233, etc.) under the FDA’s OpenFDA database. These numbers correspond to different clip dimensions tailored for various vessel diameters, ensuring compatibility with different surgical needs.

  • How do I know if the angiOCCLUDE Ligating Clips are compliant with regulatory requirements?

    The angiOCCLUDE Ligating Clips are regulated under the FDA’s 510(k) clearance process (K230966) and classified as a Class 2 device. They are deemed substantially equivalent to predicate devices and are approved for use in vascular occlusion procedures, adhering to FDA standards for implantable clips in general and plastic surgery.