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Single Use MultiClip Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K180325

by Micro-Tech (Nanjing) Co., Ltd.

Identifiers

510(k) Number
K180325 FDA 510(k)
FDA Product Code
PKL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.4400 FDA 510(k)
Regulation Number
876.4400 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Single Use MultiClip Device is a Hemostatic Metal Clip for the GI Tract, designed to apply controlled pressure to tissue to achieve hemostasis. It is classified under FDA regulation 21 CFR § 876.4400 and intended for use in gastroenterology and urology procedures, where precise clip application is required to secure bleeding vessels or tissue segments.

This device is supplied as a single-use, sterile product, intended for in-office or procedural room use. It is classified as Class II under FDA regulations and must be handled according to standard sterile instrument protocols. The device is packaged for individual use and requires no reprocessing. No MRI safety information is specified, and compliance with FDA 510(k) clearance (K180325) is noted for its intended use.

Frequently asked questions

What is the Single Use MultiClip Device used for?

The Single Use MultiClip Device is designed to achieve hemostasis by applying controlled pressure to tissue, specifically for securing bleeding vessels or tissue segments during gastroenterology and urology procedures. Its precise clip application helps prevent post-procedure bleeding in controlled environments like in-office or procedural rooms.

Is the MultiClip Device reusable or single-use?

The MultiClip Device is explicitly intended for single-use only. It is packaged sterile for individual procedures and must not be reprocessed or reused. This ensures patient safety and maintains sterility standards.

How should the MultiClip Device be stored?

As a sterile, single-use device, the MultiClip Device should be stored in its original, unopened packaging to preserve sterility. It should be kept in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use.

What regulatory approval does the MultiClip Device hold?

The MultiClip Device holds FDA 510(k) clearance under the classification 21 CFR § 876.4400, with the clearance number K180325. This indicates it has been deemed substantially equivalent to a legally marketed predicate device and is approved for its intended use in gastroenterology and urology.

Does the MultiClip Device have any MRI safety information?

The provided documentation does not specify any MRI safety information for the MultiClip Device. If MRI compatibility is required for a procedure, additional verification or alternative devices may be necessary.

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: Single Use MultiClip Device (K180325) — FDA 510(k) | Innolitics, K180325 - Single Use MultiClip Device FDA 510 (k) APPLICATION FOR Micro ..., Single Use MultiClip Device 510 (k) K180325 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Micro-Tech (Nanjing) Co., Ltd.

Sources (1)

  • FDA 510(k) K180325 24 fields · synced Oct 1, 2026