Unipro Suture, Nonabsorbable, Synthetic, Polypropylene
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- UNIPRO EUDAMED
- Device Name
- UNIPRO Sterile, Single Use, Synthetic Non-Absorbable Surgical Sutures with or without Needle EUDAMED
- Model / Reference
- UNIPRO EUDAMEDDW9198D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06285379067159 EUDAMED
- Basic UDI-DI
- B-06285379067159 EUDAMED
- 510(k) Number
- K042283 FDA 510(k)
- FDA Product Code
- GAW FDA 510(k)
- EMDN Code
- H010201010401,H010201010403 EUDAMED
Classification
- Device Class
- Class III EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.5010 FDA 510(k)
- Regulation Number
- 878.5010 FDA 510(k)
- 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 Unipro Suture is a nonabsorbable, synthetic suture made from polypropylene, classified under FDA product code GAW (878.5010). It is designed for general and plastic surgery applications, providing durable tissue approximation and ligation. Polypropylene sutures are known for their strength, minimal tissue reactivity, and resistance to degradation over time, making them suitable for long-term wound closure and internal fixation.
This suture is supplied in sterile, single-use packaging and is intended for use in surgical settings where nonabsorbable support is required. It is classified as a Class II medical device under FDA regulations and has received 510(k) clearance and MDD compliance. The device is available in multiple sizes and reference codes, as listed in the regulatory submissions, and must be stored according to manufacturer guidelines to maintain sterility and integrity. No MRI safety information is specified, and its reuse is not indicated.
Frequently asked questions
What types of surgical procedures is the Unipro Suture designed for, and why is polypropylene chosen as the material?
The Unipro Suture is specifically designed for general and plastic surgery applications, where durable tissue approximation and ligation are required. Polypropylene is the material of choice because it is a nonabsorbable, synthetic fiber known for its strength, minimal tissue reactivity, and resistance to degradation, making it ideal for long-term wound closure and internal fixation. This ensures reliable support over extended periods without causing inflammation or breaking down.
How should the Unipro Suture be stored to maintain its sterility and usability?
The Unipro Suture is supplied in sterile, single-use packaging, so it must be stored according to the manufacturer’s guidelines to preserve sterility and integrity. This typically involves keeping it in a cool, dry place away from direct sunlight or extreme temperatures, as recommended for surgical sutures. Always check the packaging for expiration dates or storage instructions before use.
Are there multiple sizes or models available for the Unipro Suture, and how would I identify the correct one for my procedure?
Yes, the Unipro Suture is available in multiple sizes and reference codes, as listed in the regulatory submissions (e.g., FEI numbers like 3003495548 or 3003639970). The correct size depends on the surgical application—thinner sutures (e.g., 3-0 or 4-0) are typically used for delicate tissues like skin or nerves, while thicker sutures (e.g., 0 or 1) are better for larger tissues or ligatures. Always refer to the packaging or manufacturer’s documentation to match the suture size to your procedure.
Can the Unipro Suture be reused, or is it intended for single-use only?
The Unipro Suture is intended for single-use only, as explicitly stated in the product description. Reusing sutures poses risks of contamination, loss of sterility, and potential tissue damage, which could compromise patient safety. Always adhere to single-use guidelines to ensure proper surgical outcomes.
What regulatory pathways has the Unipro Suture followed, and how does this affect its use in clinical settings?
The Unipro Suture has undergone FDA 510(k) clearance and complies with the MDD (Medical Device Directive), confirming it meets U.S. and European regulatory standards for Class II devices. This means it has been evaluated for safety and effectiveness in its intended use—general and plastic surgery—and can be confidently used in clinical settings where nonabsorbable sutures are required. Always verify local regulatory compliance before use.
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: United Medical Industries Limited Co L.L.C (UNIMED), UNIPRO by UNITED MEDICAL INDUSTRIES CO. LTD. | FDA 510 (k) Summary, United Medical Industries (UNIMED), United Medical Industries Limited Co L.L.C (UNIMED)
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 | K042283 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- United Medical Industries Co. Ltd
- FDA Applicant
- United Medical Industries Co. , Ltd.
Sources (2)
- FDA 510(k) K042283 24 fields · synced Sep 20, 2026
- EUDAMED de849e2d-1a86-43e8-9f38-2e5feab7293f 61 fields · synced Jul 9, 2026