Advance Suture Nonabsorbable Dacron Suture
510(k) K903175
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903175 | Date26 Jul 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GAS
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.5000
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Advance Suture Nonabsorbable Dacron Suture is a Suture, Nonabsorbable, Synthetic, Polyester device, classified under FDA regulation 878.5000. It consists of a multifilament, nonabsorbable, sterile thread made from high molecular weight, long-chain, linear polyesters containing aromatic rings. This suture is designed for soft tissue approximation in surgical procedures, providing durable closure due to its synthetic polyester composition.
Supplied as a sterile, single-use product, this suture is intended for use in general and plastic surgery settings. It is manufactured under FDA 510(k) clearance (K903175) and falls under Device Class II. The product is packaged for surgical use and adheres to regulatory standards for nonabsorbable sutures, ensuring reliability for prolonged tissue support. No MRI safety or reusable specifications are noted in the data.
Other devices from Advance Suture, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Advance Suture Nonabsorbable Dacron Suture used for?
This suture is designed specifically for soft tissue approximation in surgical procedures, providing durable closure due to its synthetic polyester composition. Its multifilament structure makes it ideal for applications requiring prolonged tissue support, such as in general and plastic surgery settings.
Is the Advance Suture Nonabsorbable Dacron Suture sterile and single-use?
Yes, the Advance Suture Nonabsorbable Dacron Suture is supplied as a sterile, single-use product. This ensures safety and reliability for surgical use, as it is intended to be used only once per patient to maintain sterility and reduce infection risks.
What materials is the Advance Suture Nonabsorbable Dacron Suture made from?
The suture is made from high molecular weight, long-chain, linear polyesters containing aromatic rings. This composition gives it its nonabsorbable properties, ensuring it remains intact in the body for extended periods to support tissue healing.
What sizes or models are available for the Advance Suture Nonabsorbable Dacron Suture?
The device is available in multiple sizes and models, as indicated by the listed FEI numbers (e.g., 3005747797, 3016851379, etc.). These variations allow clinicians to select the appropriate suture size and type for specific surgical needs, ensuring optimal performance for different tissue types and procedures.
How should the Advance Suture Nonabsorbable Dacron Suture be stored?
While the provided data does not specify storage conditions explicitly, standard practice for sterile, single-use sutures typically involves storing them in a clean, dry environment, protected from direct sunlight and extreme temperatures. Always follow the manufacturer’s instructions on the packaging for precise storage guidelines to maintain sterility and integrity.