Dermalon, Surgilon, Ophthalon, & Ophthalmic Nylon Sut
510(k) K930586
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK930586 | Date17 Dec 1993 | 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- Withdrawn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
- GAR
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.5020
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
This device is a non-absorbable synthetic suture made of polyamide (nylon), intended for general soft tissue approximation and ligation. It is indicated for use in cardiovascular, ophthalmic, and neurological procedures. The product is supplied in multiple brand names including Dermalon, Surgilon, Ophthalon, and Ophthalmic Nylon Suture, and is classified as a Class II device under product code GAR.
The suture is supplied sterile and is intended for single-use. It is non-absorbable and synthetic, designed for applications where long-term tissue support is required. The device is regulated under FDA 510(k) clearance with K-number K930586, and was authorized for market entry on December 17, 1993. Storage conditions and specific size ranges are not detailed in the available data.