GAS · Suture, Nonabsorbable, Synthetic, Polyester
General, Plastic Surgery · 21 CFR 878.5000 · Class 2
Overview
| Product Code | GAS |
|---|---|
| Device Name | Suture, Nonabsorbable, Synthetic, Polyester |
| Regulation | 21 CFR 878.5000 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (18 of 18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K203120 | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene | Lsi Solutions, Inc. | Nov 24, 2020 | SESE |
| K203081 | RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture | Lsi Solutions | Nov 24, 2020 | SESE |
| K091018 | ARTHREX BIOWIRE | Arthrex, Inc. | Jul 30, 2010 | SESE |
| K002261 | MR-III | Smith & Nephew, Inc. | Oct 23, 2000 | SESE |
| K953128 | SUTURE CORD | Phoenix Biomedical Corp. | Feb 9, 1996 | SN |
| K923161 | BRAIDED POLYESTER SUTURE MATERIAL | Mitek Surgical Products, Inc. | Dec 30, 1992 | SESE |
| K913101 | PETERS CARDIOFLON(TM) SUTURE | Promedica Products, Inc. | Aug 12, 1992 | SESE |
| K915089 | MITEK QUICKANCHOR(TM), MODIFICATION | Mitek Surgical Products, Inc. | Feb 3, 1992 | SESE |
| K915081 | MITEK SNAP PAK(TM), MODIFICATION | Mitek Surgical Products, Inc. | Jan 31, 1992 | SESE |
| K903175 | ADVANCE SUTURE NONABSORBABLE DACRON SUTURE | Advance Suture, Inc. | Jul 26, 1991 | SESE |
| K905285 | IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES | Internacional Farmaceutica, S.A. DE C.V. | Feb 11, 1991 | SESE |
| K905440 | FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE | United States Surgical, A Division of Tyco Healthc | Jan 31, 1991 | SESE |
| K904535 | LU-TEX II | Lukens Medical Corp. | Jan 30, 1991 | SESE |
| K904436 | QUICKANCHOR (TM) | Mitek Surgical Products, Inc. | Dec 11, 1990 | SESE |
| K904263 | DACRON R SURGICAL SUTURES | Sharppoint, Inc. | Oct 16, 1990 | SESE |
| K904054 | POLYVIOLENE(TM) SUTURE | Look, Inc. | Oct 3, 1990 | SESE |
| K902873 | NONABSORBABLE DACRON SURGICAL SUTURE* | United States Surgical, A Division of Tyco Healthc | Sep 27, 1990 | SN |
| P880094 | DACRON SURGICAL SUTURES | Alcon Laboratories | Sep 22, 1989 | APRL |
Top Applicants
- Mitek Surgical Products, Inc. — 4 clearances
- United States Surgical, A Division of Tyco Healthc — 2 clearances
- Smith & Nephew, Inc. — 1 clearance
- Sharppoint, Inc. — 1 clearance
- Promedica Products, Inc. — 1 clearance
