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InnoClip Disposable Clip Applier

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K253903

by Taiwan Surgical Corporation

Identifiers

510(k) Number
K253903 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 InnoClip Disposable Clip Applier is a Clip, Implantable device, designed for the application of surgical clips in general and plastic surgery procedures. These clips are used to occlude blood vessels, ducts, or other tubular structures, aiding in hemostasis and tissue separation during operations such as hernia repair, breast surgery, or vascular procedures.

The device is supplied as a disposable, single-use applicator intended for sterile surgical environments. It is classified as Class II under FDA regulations and has received FDA 510K clearance and MDD authorization. The applicator is non-reusable and must be discarded after use to ensure sterility and prevent cross-contamination. No specific MRI safety information is provided, and the device is not intended for reusable applications.

Frequently asked questions

What types of surgical procedures is the InnoClip Disposable Clip Applier intended for, and how does it function in those settings?

The InnoClip Disposable Clip Applier is designed for general and plastic surgery procedures, where it is used to apply surgical clips to occlude blood vessels, ducts, or tubular structures. This helps achieve hemostasis (stopping blood flow) and separates tissues during operations like hernia repair, breast surgery, or vascular procedures. The clips ensure a secure closure to minimize bleeding and promote proper healing.

Is the InnoClip Disposable Clip Applier reusable, and what are the implications of its single-use design?

No, the InnoClip Disposable Clip Applier is explicitly designed for single-use only and must be discarded after application. This design ensures sterility and prevents cross-contamination between patients, which is critical in sterile surgical environments. Reusing it could compromise patient safety by introducing infection risks or compromising clip integrity.

How should the InnoClip Disposable Clip Applier be stored, and are there any special handling requirements?

The device is supplied as a sterile, disposable applicator intended for surgical use. Storage should follow standard sterile medical device protocols—keep it in its original packaging, protected from moisture, dust, and extreme temperatures. Avoid exposure to direct sunlight or contamination. Since it’s single-use, ensure it remains unopened until immediately before use to maintain sterility.

What regulatory pathways has the InnoClip Disposable Clip Applier undergone, and how does this affect its use in clinical settings?

The InnoClip Disposable Clip Applier has received FDA 510(k) clearance and MDD authorization, confirming it meets regulatory standards for safety and effectiveness. Its classification as Class II under FDA regulations indicates it undergoes additional scrutiny but is not considered high-risk. Clinicians can rely on its compliance with these pathways, though local healthcare regulations should always be consulted for specific use guidelines.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Taiwan Surgical Corporation

Sources (2)

  • FDA 510(k) K253903 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 19, 2026