GAS — Suture, Nonabsorbable, Synthetic, Polyester Class II
FDA product code GAS covers "Suture, Nonabsorbable, Synthetic, Polyester", a Class II medical device regulated under 21 CFR 878.5000. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 17 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GAS
- Device Class
- Class II
- Regulation Number
- 878.5000
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K203120 | lsi solutions | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK | November 24, 2020 |
| K203081 | lsi solutions | RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture | November 24, 2020 |
| K091018 | arthrex | ARTHREX BIOWIRE | July 30, 2010 |
| K002261 | smith and nephew | MR-III | October 23, 2000 |
| K953128 | phoenix biomedical | SUTURE CORD | February 9, 1996 |
| K923161 | mitek surgical products | BRAIDED POLYESTER SUTURE MATERIAL | December 30, 1992 |
| K913101 | promedica products | PETERS CARDIOFLON(TM) SUTURE | August 12, 1992 |
| K915089 | mitek surgical products | MITEK QUICKANCHOR(TM), MODIFICATION | February 3, 1992 |
| K915081 | mitek surgical products | MITEK SNAP PAK(TM), MODIFICATION | January 31, 1992 |
| K903175 | advance suture | ADVANCE SUTURE NONABSORBABLE DACRON SUTURE | July 26, 1991 |
| K905285 | internacional farmaceutica, s.a. de c.v | IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES | February 11, 1991 |
| K905440 | united states surgical, a division of tyco healthc | FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE | January 31, 1991 |
| K904535 | lukens medical | LU-TEX II | January 30, 1991 |
| K904436 | mitek surgical products | QUICKANCHOR (TM) | December 11, 1990 |
| K904263 | sharppoint | DACRON R SURGICAL SUTURES | October 16, 1990 |
| K904054 | look | POLYVIOLENE(TM) SUTURE | October 3, 1990 |
| K902873 | united states surgical, a division of tyco healthc | NONABSORBABLE DACRON SURGICAL SUTURE* | September 27, 1990 |