Dacron Surgical Sutures
PMA P880094
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP880094 | Date22 Sep 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Suture, nonabsorbable, synthetic, polyester
- FDA applicant
- Alcon Laboratories
- PMA Number
- FDA Product Code
- GAS
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.5000
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- APRL
Overview
AI-generated summary, 18 Sep 2026
The Dacron Surgical Sutures are nonabsorbable, synthetic, polyester sutures designed for tissue approximation and ligation in surgical procedures. These sutures are classified as Class II medical devices under FDA regulations, intended for use in general and plastic surgery applications.
These sutures are supplied in sterile, single-use packaging and are intended for use in controlled surgical environments. They are available in various sizes and reference codes as listed in the specifications, adhering to FDA-authorized standards under PMA number P880094. Compliance with regulation number 878.5000 ensures their suitability for approved medical applications.
Other devices from Alcon Laboratories, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are Dacron Surgical Sutures reusable or intended for single-use only, and how should they be stored once opened?
Dacron Surgical Sutures are supplied in sterile, single-use packaging, meaning each package is designed for one surgical procedure only. Once opened, the sutures should not be reused to maintain sterility and prevent contamination. Unopened packages should be stored in a clean, dry environment, away from direct sunlight and extreme temperatures, following the manufacturer’s guidelines to preserve their sterile condition.
What types of surgical procedures are these sutures primarily used for, and what makes them suitable for those applications?
These sutures are designed for tissue approximation and ligation in general and plastic surgery procedures. They are nonabsorbable and made of synthetic polyester, which provides strength and durability over time, making them ideal for procedures requiring long-term wound support or where prolonged tissue integrity is critical.
How do I identify the correct size or model of Dacron Surgical Sutures for my specific surgical need?
Dacron Surgical Sutures come in multiple sizes and reference codes, as listed in the specifications. The correct size depends on the surgical application—thicker sutures (lower gauge numbers) are typically used for heavier tissues, while finer sutures (higher gauge numbers) are better suited for delicate work. Always refer to the product’s packaging or consult the manufacturer’s documentation to match the suture to your procedure’s requirements.
What regulatory pathway was followed for the approval of these sutures, and what does that mean for their use in clinical settings?
The Dacron Surgical Sutures were approved through the FDA’s Premarket Approval (PMA) process under PMA number P880094, which is a rigorous review pathway for higher-risk medical devices. This approval ensures the sutures meet established safety and effectiveness standards for use in surgical procedures, giving clinicians confidence in their reliability for tissue approximation and ligation in general and plastic surgery.