← Back to catalogue

UltraClip II MR

FDA 510(k)

Class II (US FDA 510(k))

510(k) K041201

by Inrad

Identifiers

510(k) Number
K041201 FDA 510(k)
FDA Product Code
GDW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4750 FDA 510(k)
Regulation Number
878.4750 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The UltraClip II MR is an implantable staple, classified under FDA product code GDW (General, Plastic Surgery) and regulation 878.4750. This device is designed as a tissue marker intended for use in surgical procedures, providing a means to identify anatomical landmarks or areas of interest within soft tissue. Its construction allows for secure fixation while remaining compatible with MRI environments, ensuring safe imaging post-implantation.

The UltraClip II MR is supplied as a sterile, single-use device and is intended for use in MRI-safe settings. It is available in multiple sizes, as referenced by its FEI numbers, and is regulated under FDA 510(k) clearance (K041201) with a decision of substantial equivalence. Storage and handling must comply with sterile medical device protocols, and its design adheres to MRI safety standards to prevent interference during imaging procedures.

Frequently asked questions

What is the primary purpose of the UltraClip II MR in surgical procedures?

The UltraClip II MR is designed as an implantable tissue marker to help identify anatomical landmarks or areas of interest within soft tissue during surgery. Its secure fixation ensures visibility and localization, particularly in settings where MRI compatibility is required for post-procedure imaging.

How many sizes or models are available for the UltraClip II MR, and how are they identified?

The UltraClip II MR comes in multiple sizes, each identified by a unique FEI (Federal Equipment Identifier) number. Over 100 distinct FEI numbers are listed, such as 3011052945, 3003495548, and others, allowing for a range of applications depending on the surgical needs.

Is the UltraClip II MR intended for reuse, or is it a single-use device?

The UltraClip II MR is explicitly supplied as a sterile, single-use device. This ensures patient safety and compliance with sterile medical device protocols, preventing contamination or cross-infection risks associated with reuse.

What special considerations should be taken for storage and handling of the UltraClip II MR?

Since the UltraClip II MR is sterile and single-use, storage must follow strict sterile medical device protocols to maintain its integrity. Additionally, its design adheres to MRI safety standards, meaning it should be stored in a way that prevents damage or interference with its compatibility for post-implantation imaging.

How does the UltraClip II MR ensure safety during MRI procedures after implantation?

The UltraClip II MR is explicitly designed to be MRI-safe, meaning it does not interfere with MRI imaging equipment or produce artifacts that could compromise diagnostic accuracy. This makes it suitable for use in procedures where post-operative MRI scans are required.

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: Object Info: - MRI Safety, Ultraclip Ii Mr - Beudamed

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
Inrad

Sources (1)

  • FDA 510(k) K041201 24 fields · synced Sep 20, 2026