M/L-10 Clip Applier Sterilization Tray (Catalog# 3706)
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- M/L-10 EUDAMEDFDA UDI
- Generic Name
- Open-surgery ligation clip applier FDA UDI
- Device Name
- M/L-10 Multi-Fire Clip Applier EUDAMEDM/L-10 Multi-Fire Clip Applier, Reusable FDA UDI
- Model / Reference
- 1002 EUDAMEDFDA UDI
- Description
- M/L-10 Multi-Fire Clip Applier, Reusable FDA UDI
Identifiers
- Catalog Number
- 1002 FDA UDI
- Primary DI / UDI-DI
- 00811099010388 EUDAMEDFDA UDI
- Basic UDI-DI
- 081109901DOC001S5 EUDAMED
- Direct Marketing DI
- 00811099010388 EUDAMED
- 510(k) Number
- K152743 FDA 510(k)
- FDA Product Code
- KCT FDA 510(k)GCJ FDA UDI
- EMDN Code
- H03010105 REUSABLE MULTIPLE CLIP APPLIER CARTRIDGES FOR OPEN SURGERY EUDAMED
- GMDN Term
- Open-surgery ligation clip applier FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 880.6850 FDA 510(k)
- Regulation Number
- 880.6850 FDA 510(k)876.1500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The M/L-10 Clip Applier Sterilization Tray is a protective container designed to secure and transport the M/L-10 Clip Applier handpiece during sterilization, storage, and handling. Constructed from stainless steel, it includes a case, cover, silicone brackets, and aluminum components to ensure structural integrity while allowing steam penetration and air removal for effective sterilization. This tray is intended for use with the M/L-10 Clip Applier (Catalog #1002) and is classified under product code KCT. Its design facilitates proper sterilization processes when paired with FDA-cleared 1-ply polypropylene wrap.
The sterilization tray is reusable and intended for use in general hospital settings. It is not sterile upon receipt and must be sterilized prior to first use, typically via steam sterilization. The tray’s dimensions and materials are optimized for compatibility with standard sterilization equipment and procedures. Regulatory authorizations include FDA 510K clearance under the General Hospital advisory committee and compliance with the Medical Device Regulation (MDR). No specific MRI safety classification or single-use designation is stated in the specifications.
Frequently asked questions
Is this sterilization tray designed for single-use or can it be reused multiple times?
This tray is explicitly designed for reuse—it is not marked as single-use. However, it must be properly sterilized before its first use and after each subsequent use to maintain safety and prevent contamination. The stainless steel construction and aluminum components are built to withstand repeated sterilization cycles, including steam sterilization, ensuring durability for hospital settings.
How should I prepare the tray for sterilization before its first use?
The tray is not sterile upon receipt and requires sterilization prior to first use. It is designed to work with FDA-cleared 1-ply polypropylene wrap and standard sterilization equipment. Follow your facility’s steam sterilization protocols, ensuring proper wrapping and steam penetration to achieve effective sterilization. The tray’s materials (stainless steel, silicone brackets, and aluminum) are optimized for compatibility with these processes.
What sizes or models of the M/L-10 Clip Applier does this sterilization tray accommodate?
This tray is specifically designed for the M/L-10 Clip Applier handpiece (Catalog #1002). It includes protective components like silicone brackets and a case to securely hold and transport the device during sterilization, storage, and handling. No additional sizes or models are mentioned in the specifications.
Can this tray be used in any hospital setting, or are there specific requirements for its use?
The tray is intended for general hospital settings and is reusable, making it suitable for routine use in surgical or procedural environments. While no specific MRI safety classification is stated, its design prioritizes compatibility with standard sterilization equipment and procedures, including steam sterilization. Always follow your facility’s protocols for sterilization and handling to ensure safe use.
What regulatory pathways does this device follow, and how does that affect its use?
This tray holds FDA 510K clearance under the General Hospital advisory committee (product code KCT) and complies with the Medical Device Regulation (MDR). The clearance indicates it is deemed substantially equivalent to a predicate device, meaning it meets established safety and performance standards for its intended use. While the regulatory route confirms its suitability for hospital sterilization and handling, it does not alter clinical indications—only that it is designed to safely transport and sterilize the paired M/L-10 Clip Applier.
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: PDF M/L-10 Clip Applier Sterilization Tray ... - Microline Surgical, PDF M/L-10 Clip Applier Sterilization Tray Instructions For Use, M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K152743 | Class II | Active |
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Manufacturer
- Manufacturer
- Microline Surgical, Inc.
Sources (3)
- FDA 510(k) K152743 24 fields · synced Sep 20, 2026
- FDA UDI e946e54a-5bb0-496d-9a11-160deb70b600 34 fields · synced May 30, 2026
- EUDAMED 70447b01-fc43-4c1b-b4b6-21c4b18651c3 61 fields · synced Jul 9, 2026