Nylon Nonabsorbable Surgical Sutures, Usp
by Arc Medical Supplies (Beijing) Co, Ltd.
510(k) K000539
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK000539 | Date27 Apr 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- Withdrawn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
- GAR
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.5020
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SN
Overview
AI-generated summary, 22 Sep 2026
The Nylon Nonabsorbable Surgical Sutures, Usp is a type of suture, nonabsorbable, synthetic, polyamide. It is used as a surgical suture.
The device is supplied by Arc Medical Supplies (Beijing) Co, Ltd. and has FDA 510(k) clearance, with a regulation number of 878.5020. The product code is GAR and it is classified as a class 2 device.
Other devices from Arc Medical Supplies (Beijing) Co, Ltd.
Questions
AI-generated answers, 22 Sep 2026
What is the Nylon Nonabsorbable Surgical Sutures used for?
The Nylon Nonabsorbable Surgical Sutures are used as a surgical suture, specifically for procedures requiring a nonabsorbable, synthetic polyamide material.
Is the Nylon Nonabsorbable Surgical Sutures supplied sterile?
The device data does not explicitly state that the sutures are supplied sterile, it is essential to follow proper sterilization procedures before use.
What is the regulatory classification of the Nylon Nonabsorbable Surgical Sutures?
The device is classified as a class 2 device with a regulation number of 878.5020 and product code GAR.