Visitec Microsurgical Suture
by Visitec Co. 510(k)
Active
510(k) K922530
Overview
This device is a Suture, Nonabsorbable, Synthetic, Polyamide, as defined in the device data. It is a microsurgical suture manufactured by Visitec Co.
It is supplied as a single-use device, cleared via FDA 510(k) (K922530) on October 20, 1992, and classified as Class II with product code GAR. The device is intended for use in general and plastic surgery settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK922530 | Date20 Oct 1992 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Visitec Co.
Questions
What is the Visitec Microsurgical Suture used for?
The Visitec Microsurgical Suture is intended for use in general and plastic surgery settings as a nonabsorbable synthetic polyamide suture for approximating and ligating tissue during microsurgical procedures.
How is the Visitec Microsurgical Suture supplied and is it reusable?
The device is supplied as a single-use suture and is not designed for reuse; it must be discarded after one procedure to ensure patient safety and maintain sterility.
What regulatory pathway was used for the Visitec Microsurgical Suture?
The Visitec Microsurgical Suture was cleared via the FDA 510(k) process under submission K922530, determined to be substantially equivalent to a predicate device, and is classified as Class II with product code GAR.