Ethibond Suture, Nonabsorbable, Synthetic, Polyester
PMA N17809
Active
Valid until
No expiry
FDA recalls
None foundDocuments
PMA N17809
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberN17809 | Date2 May 1984 | 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- Withdrawn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
- Full name
- Ethibond*
- Generic name
- Suture, nonabsorbable, synthetic, polyester
- FDA applicant
- ETHICON, Inc.
- PMA number
- FDA product code
- GAS
- Device class
- Class II
- Regulation
- 21 CFR Part 878.5000
- Advisory committee
- General, Plastic Surgery
- FDA decision
- APPR Approved
- PMA supplement
- S006
Overview
AI-generated summary, 18 Sep 2026
Ethibond is a nonabsorbable, synthetic polyester suture designed for general and plastic surgery applications. It provides durable tissue support and is formulated to maintain tensile strength over extended periods, making it suitable for procedures requiring prolonged wound stability.
Ethibond sutures are supplied in sterile, single-use packaging and are classified as Class II devices under FDA regulations. They are available in various sizes and configurations, including braided and monofilament variants, and are intended for use in soft tissue approximation and ligation. Storage requires protection from moisture and extreme temperatures to preserve sterility and integrity.
Other devices from Ethicon Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of surgical procedures is Ethibond suture commonly used for, and why is it preferred in those settings?
Ethibond is designed for general and plastic surgery applications, particularly where durable tissue support and prolonged wound stability are required. Its nonabsorbable, synthetic polyester composition ensures it retains tensile strength over extended periods, making it ideal for procedures like soft tissue approximation and ligation where long-term suture integrity is critical.
Is Ethibond suture available in multiple configurations, and if so, what are the key differences between them?
Yes, Ethibond sutures are available in both braided and monofilament variants. The braided version offers higher knot security and flexibility, which can be advantageous for delicate tissues, while the monofilament variant reduces tissue drag and is less likely to harbor bacteria, making it suitable for applications where infection risk is a concern.
How should Ethibond suture be stored to maintain its sterility and performance?
Ethibond sutures must be stored in their original, sterile packaging to protect them from moisture and extreme temperatures. Exposure to these conditions can compromise sterility and degrade the suture’s structural integrity, so it’s important to keep them in a dry, controlled environment until use.
Are Ethibond sutures intended for single-use only, and what does that mean for clinical workflows?
Yes, Ethibond sutures are supplied in sterile, single-use packaging, meaning each package is designed for one-time use only. This ensures sterility and prevents cross-contamination between patients, which is critical in clinical settings where infection control is paramount.
What regulatory pathway was followed for Ethibond suture, and what does that indicate about its approval status?
Ethibond suture underwent a Premarket Approval (PMA) process through the FDA, as indicated by the PMA number (N17809). This pathway is typically required for higher-risk medical devices, and its approval signifies that the device has been thoroughly evaluated for safety and effectiveness in its intended surgical applications.