POLYESTER NONABSORBABLE SURGICAL SUTURES, USP
Device Facts
| Record ID | K000540 |
|---|---|
| Device Name | POLYESTER NONABSORBABLE SURGICAL SUTURES, USP |
| Applicant | Arc Medical Supplies (Beijing) Co, Ltd. |
| Product Code | GAT · General, Plastic Surgery |
| Decision Date | Apr 27, 2000 |
| Decision | SN |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.5000 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
