CLIP PLUS Disposable Clip Applier, ML +1 more model
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- "Taiwan Surgical" Disposable Clip Applier EUDAMED
- Model / Reference
- TDC-10-ML, TDC-10-L, DCXT1-BX, DCXT1-LX, DC5T1-BX, DC5T1-B6 EUDAMEDNone EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-471748090DCTL9 EUDAMED
- Basic UDI-DI
- B-471748090DCTL9 EUDAMED
- 510(k) Number
- K150259 FDA 510(k)
- FDA Product Code
- FZP FDA 510(k)
- EMDN Code
- H03020101 SINGLE-USE MULTIPLE CLIP APPLIERS FOR VIDEOSURGERY EUDAMED
- Models / Variants
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4300 FDA 510(k)
- Regulation Number
- 878.4300 FDA 510(k)
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Clip Plus Disposable Clip Applier is a surgical device classified as a Clip, Implantable, designed for the application of surgical clips to tissues. It is intended for use in general and plastic surgery procedures, facilitating the secure closure of blood vessels or ducts during operations.
This device is supplied as a single-use, sterile disposable item in two sizes: ML and L. It is intended for use in controlled surgical environments and complies with FDA 510K and MDD authorizations. The device is non-magnetic and does not contain components that would interfere with MRI safety, though its use in MRI environments should be confirmed with the manufacturer.
Frequently asked questions
What types of surgical procedures is the Clip Plus Disposable Clip Applier designed for, and how does it help during those procedures?
The Clip Plus Disposable Clip Applier is designed for use in general and plastic surgery procedures. It is intended to securely close blood vessels or ducts during operations, ensuring hemostasis and preventing complications like bleeding or leakage. The device facilitates precise and efficient clip application, which is critical in these types of surgeries where tissue integrity and safety are paramount.
Are the Clip Plus Disposable Clip Appliers reusable or single-use, and what does this mean for my workflow?
The Clip Plus Disposable Clip Appliers are explicitly designed as single-use items. This means each device is intended for one surgical procedure only, ensuring sterility and reducing the risk of cross-contamination. For your workflow, this simplifies inventory management and eliminates the need for cleaning or sterilization between uses, as you would with reusable instruments.
What sizes are available for the Clip Plus Disposable Clip Applier, and how do I determine which size to use?
The Clip Plus Disposable Clip Applier is available in two sizes: ML (Medium-Large) and L (Large). The choice of size depends on the specific anatomical structures you are working with during surgery. Larger vessels or ducts typically require the L size, while medium-sized vessels or ducts are better suited for the ML size. Consulting preoperative imaging or surgical guidelines can help guide your selection.
Can the Clip Plus Disposable Clip Applier be used in an MRI environment, and what precautions should I take?
The Clip Plus Disposable Clip Applier is explicitly stated to be non-magnetic and does not contain components that interfere with MRI safety. However, the manufacturer advises confirming its use in MRI environments with them directly, as safety protocols may vary based on specific MRI equipment and settings. Always follow your facility’s MRI safety guidelines and consult the manufacturer for the most up-to-date recommendations.
How should the Clip Plus Disposable Clip Applier be stored to maintain its sterility and functionality?
Since the Clip Plus Disposable Clip Applier is sterile and single-use, it should be stored in its original, sealed packaging until the moment of use. Store the device in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of contamination. Ensure the packaging remains intact to preserve sterility and functionality until the procedure begins.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K150259 | Class II | Active |
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Manufacturer
- Manufacturer
- Taiwan Surgical Corporation
Sources (3)
- FDA 510(k) K150259 24 fields · synced Sep 18, 2026
- EUDAMED 6f1a8e75-d944-4e9a-a7ce-f4b7ee78b91b-1 61 fields · synced Jul 10, 2026
- EUDAMED 6f1a8e75-d944-4e9a-a7ce-f4b7ee78b91b-2 61 fields · synced Jul 10, 2026