Product code GAS
- Device name
- Suture, Nonabsorbable, Synthetic, Polyester
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.5000
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P840041S006 | NOVAFIL(R) AND VASCUFIL(R) POLYBUTESTER MONOFILAMENT NONABSORBABLE SURGICAL SUTURE | Davis & Geck, Inc. | 1996-01-11 |
| P840041S005 | NOVAFIL(TM) | Davis & Geck, Inc. | 1994-04-20 |
| P840041S003 | NOVAFIL(TM) | Davis & Geck, Inc. | 1990-07-06 |
| P880094 | DACRON SURGICAL SUTURES | Alcon Laboratories | 1989-09-22 |
| P840041S004 | NOVAFIL(TM) | Davis & Geck, Inc. | 1989-08-08 |
| N17804S038 | ETHIBOND* | ETHICON, Inc. | 1988-12-22 |
| N17804S037 | ETHIBOND* | ETHICON, Inc. | 1987-08-28 |
| N17804S036 | ETHIBOND* | ETHICON, Inc. | 1987-06-18 |
| P840041S002 | NOVAFIL(TM) | Davis & Geck, Inc. | 1987-06-05 |
| N83509S011 | NON-ABSORBABLE (POLYESTER FIBER) SUTURES | Davis & Geck, Inc. | 1987-06-05 |
| N83509S010 | NON-ABSORBABLE (POLYESTER FIBER) SUTURES | Davis & Geck, Inc. | 1987-02-20 |
| P840041S001 | NOVAFIL(TM) | Davis & Geck, Inc. | 1987-01-13 |
| N17809S012 | ETHIBOND* | ETHICON, Inc. | 1986-12-03 |
| N17804S035 | ETHIBOND* | ETHICON, Inc. | 1986-12-03 |
| N83509S009 | NON-ABSORBABLE (POLYESTER FIBER) SUTURES | Davis & Geck, Inc. | 1986-11-17 |
| N83509S008 | NON-ABSORBABLE (POLYESTER FIBER) SUTURES | Davis & Geck, Inc. | 1986-09-30 |
| N17809S011 | ETHIBOND* | ETHICON, Inc. | 1986-06-20 |
| N17804S034 | ETHIBOND* | ETHICON, Inc. | 1986-06-20 |
| N80950S003 | POLYVIOLENE SUTURE | Look, Inc. | 1986-06-09 |
| N80950S002 | POLYVIOLENE SUTURE | Look, Inc. | 1986-02-28 |
| N80950S001 | POLYVIOLENE SUTURE | Look, Inc. | 1985-03-22 |
| N17809S010 | ETHIBOND* | ETHICON, Inc. | 1985-02-28 |
| N17804S033 | ETHIBOND* | ETHICON, Inc. | 1985-02-28 |
| N17809S006 | ETHIBOND* | ETHICON, Inc. | 1984-05-02 |
| N17804S029 | ETHIBOND* | ETHICON, Inc. | 1984-05-02 |
| N17809S009 | ETHIBOND* | ETHICON, Inc. | 1984-03-27 |
| N17804S032 | ETHIBOND* | ETHICON, Inc. | 1984-03-27 |
| N17809S008 | ETHIBOND* | ETHICON, Inc. | 1983-07-14 |
| N17804S031 | ETHIBOND* | ETHICON, Inc. | 1983-07-14 |
| N17809S007 | ETHIBOND* | ETHICON, Inc. | 1983-06-07 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203081 | RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture | Lsi Solutions | 2020-11-24 |
| K203120 | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene | Lsi Solutions, Inc. | 2020-11-24 |
| K091018 | ARTHREX BIOWIRE | Arthrex, Inc. | 2010-07-30 |
| K002261 | MR-III | Smith & Nephew, Inc. | 2000-10-23 |
| K953128 | SUTURE CORD | Phoenix Biomedical Corp. | 1996-02-09 |
| K923161 | BRAIDED POLYESTER SUTURE MATERIAL | Mitek Surgical Products, Inc. | 1992-12-30 |
| K913101 | PETERS CARDIOFLON(TM) SUTURE | Promedica Products, Inc. | 1992-08-12 |
| K915089 | MITEK QUICKANCHOR(TM), MODIFICATION | Mitek Surgical Products, Inc. | 1992-02-03 |
| K915081 | MITEK SNAP PAK(TM), MODIFICATION | Mitek Surgical Products, Inc. | 1992-01-31 |
| K903175 | ADVANCE SUTURE NONABSORBABLE DACRON SUTURE | Advance Suture, Inc. | 1991-07-26 |
| K905285 | IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES | Internacional Farmaceutica, S.A. DE C.V. | 1991-02-11 |
| K905440 | FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE | United States Surgical, A Division of Tyco Healthc | 1991-01-31 |
| K904535 | LU-TEX II | Lukens Medical Corp. | 1991-01-30 |
| K904436 | QUICKANCHOR (TM) | Mitek Surgical Products, Inc. | 1990-12-11 |
| K904263 | DACRON R SURGICAL SUTURES | Sharppoint, Inc. | 1990-10-16 |
| K904054 | POLYVIOLENE(TM) SUTURE | Look, Inc. | 1990-10-03 |
| K902873 | NONABSORBABLE DACRON SURGICAL SUTURE* | United States Surgical, A Division of Tyco Healthc | 1990-09-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840277409133 | PolyBond | RIVERPOINT MEDICAL, LLC | 2025-06-18 |
| 00840277408457 | Riverbond | RIVERPOINT MEDICAL, LLC | 2025-06-18 |
| 00840277408440 | Riverbond | RIVERPOINT MEDICAL, LLC | 2025-06-18 |
| 00840277408433 | Riverbond | RIVERPOINT MEDICAL, LLC | 2025-06-18 |
| 00840277408426 | Riverbond | RIVERPOINT MEDICAL, LLC | 2025-06-18 |
| 00840277408419 | Polybond | RIVERPOINT MEDICAL, LLC | 2025-06-18 |
| 00840277408402 | Polybond | RIVERPOINT MEDICAL, LLC | 2025-06-18 |
| 00840277408396 | Polybond | RIVERPOINT MEDICAL, LLC | 2025-06-18 |
| 00840277408389 | Polybond | RIVERPOINT MEDICAL, LLC | 2025-06-18 |
| 10886705001163 | VERSALOK | Medos International Sàrl | 2025-04-30 |
| 00812444028317 | SharpShooter Surgical Suture | RIVERPOINT MEDICAL, LLC | 2018-08-15 |
| 00380651896116 | A.C.S® (Alcon Closure System) | Alcon Laboratories, Inc. | 2017-11-30 |
| 00380651894112 | A.C.S® (Alcon Closure System) | Alcon Laboratories, Inc. | 2017-11-30 |
| 00380652131018 | A.C.S® (Alcon Closure System) | Alcon Laboratories, Inc. | 2015-10-24 |
| 00380651895119 | A.C.S® (Alcon Closure System) | Alcon Laboratories, Inc. | 2015-10-24 |
| 00380652111010 | A.C.S® (Alcon Closure System) | Alcon Laboratories, Inc. | 2015-10-24 |
| 00380652176019 | A.C.S® (Alcon Closure System) | Alcon Laboratories, Inc. | 2015-10-24 |
| 00380652152013 | A.C.S® (Alcon Closure System) | Alcon Laboratories, Inc. | 2015-10-24 |
| 00380652151016 | A.C.S® (Alcon Closure System) | Alcon Laboratories, Inc. | 2015-10-24 |
| 00380652132015 | A.C.S® (Alcon Closure System) | Alcon Laboratories, Inc. | 2015-10-24 |
| 00380652112017 | A.C.S® (Alcon Closure System) | Alcon Laboratories, Inc. | 2015-10-24 |
| 00812444021868 | RIVERBOND | RIVERPOINT MEDICAL, LLC | 2015-10-16 |
| 10886705010257 | RAPIDLOC ETHIBOND | DEPUY MITEK, LLC | 2015-09-01 |
| 10886705010233 | RAPIDLOC PANACRYL | DEPUY MITEK, LLC | 2015-09-01 |
| 10886705010226 | RAPIDLOC PANACRYL | DEPUY MITEK, LLC | 2015-09-01 |
| 10886705008223 | FASTIN ETHIBOND | DEPUY MITEK, LLC | 2015-09-01 |
| 10886705005376 | GII ETHIBOND | DEPUY MITEK, LLC | 2015-09-01 |
| 10886705002085 | BIOKNOTLESS ORTHOCORD ETHIBOND | Medos International Sàrl | 2015-09-01 |
| 10886705001224 | VERSALOK ORTHOCORD | Medos International Sàrl | 2015-09-01 |
| 10886705001101 | LUPINE ORTHOCORD | Medos International Sàrl | 2015-09-01 |