Ethibond Excel Valve Loop Suture
by Ethicon Inc.
510(k) K003070
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK003070 | Date7 Nov 2000 | 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- Withdrawn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
- DXZ
- FDA applicant
- ETHICON, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 870.3470
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Ethibond Excel Valve Loop Suture is a nonabsorbable, braided polyester suture designed for cardiovascular applications. It falls under the category of patch, pledget, and intracardiac devices, featuring a polyfilament structure composed of Poly (ethylene terephthalate) (PET). This suture is intended for use in surgical procedures requiring durable, long-term tissue approximation, particularly in cardiac valve repairs or reconstructions.
Supplied as a sterile, single-use device, the Ethibond Excel Valve Loop Suture is regulated under FDA 510K clearance (K003070) and classified as a Class II medical device (regulation number 870.3470). It is intended for use in controlled surgical environments and must be handled according to standard aseptic techniques. The suture is available in various sizes and configurations, as referenced by the associated FEI numbers, and is intended exclusively for professional medical use in cardiovascular procedures.
Other devices from Ethicon Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of cardiovascular procedures is the Ethibond Excel Valve Loop Suture specifically designed for?
The Ethibond Excel Valve Loop Suture is designed for cardiovascular procedures requiring durable, long-term tissue approximation, particularly in cardiac valve repairs or reconstructions. Its braided polyester construction ensures strength and stability, making it suitable for intricate valve loop applications where sustained support is critical.
Is this suture meant for single-use only, and if so, how should it be stored to maintain sterility?
Yes, the Ethibond Excel Valve Loop Suture is supplied as a sterile, single-use device. To preserve sterility, it should be stored in its original, unopened packaging in a dry, clean environment away from direct sunlight or extreme temperatures. Follow standard aseptic techniques when handling to prevent contamination before use.
What sizes or configurations are available for the Ethibond Excel Valve Loop Suture, and how are they identified?
The suture is available in multiple sizes and configurations, each identified by unique FEI numbers (e.g., 2183620, 1526611, etc.). These numbers correspond to specific product variants, allowing clinicians to select the appropriate size for their procedure. The full list of FEI numbers is provided in the regulatory documentation.
How is this suture regulated, and what does its classification as a Class II device imply for its use?
The Ethibond Excel Valve Loop Suture is regulated under FDA 510K clearance (K003070) and classified as a Class II medical device (regulation number 870.3470). This classification means it undergoes special controls to ensure safety and effectiveness, including performance standards and post-market surveillance, while still requiring professional medical judgment for use in controlled surgical environments.