Product code GAR
- Device name
- Suture, Nonabsorbable, Synthetic, Polyamide
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.5020
- 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 |
|---|---|---|---|
| N80838S017 | SUPRAMID EXTRA SUTURES | S. Jackson, Inc. | 1990-01-26 |
| N80838S016 | SUPRAMID EXTRA SUTURES | S. Jackson, Inc. | 1989-10-19 |
| N80838S014 | SUPRAMID EXTRA SUTURES | S. Jackson, Inc. | 1989-08-02 |
| N85060S007 | NONABSORBABLE SURG. SUTURES, NYLON | Deknatel, Inc. | 1989-06-16 |
| N80838S015 | SUPRAMID EXTRA SUTURES | S. Jackson, Inc. | 1989-06-08 |
| N85060S005 | NONABSORBABLE SURG. SUTURES, NYLON | Deknatel, Inc. | 1989-01-31 |
| N85316S016 | ETHILON/NUROLON NYLON SUTURES | ETHICON, Inc. | 1988-12-22 |
| N80838S013 | SUPRAMID EXTRA SUTURES | S. Jackson, Inc. | 1988-08-31 |
| N85060S003 | NONABSORBABLE SURG. SUTURES, NYLON | Deknatel, Inc. | 1988-07-14 |
| N85060S006 | NONABSORBABLE SURG. SUTURES, NYLON | Deknatel, Inc. | 1988-04-28 |
| N85060S004 | NONABSORBABLE SURG. SUTURES, NYLON | Deknatel, Inc. | 1988-02-22 |
| N80838S012 | SUPRAMID EXTRA SUTURES | S. Jackson, Inc. | 1987-09-09 |
| N85316S015 | ETHILON/NUROLON NYLON SUTURES | ETHICON, Inc. | 1987-08-28 |
| N80838S011 | SUPRAMID EXTRA SUTURES | S. Jackson, Inc. | 1987-06-29 |
| N85316S014 | ETHILON/NUROLON NYLON SUTURES | ETHICON, Inc. | 1987-06-18 |
| N83511S010 | NON-ABSORBABLE SUTURES NYLON | Davis & Geck, Inc. | 1987-06-05 |
| N83511S009 | NON-ABSORBABLE SUTURES NYLON | Davis & Geck, Inc. | 1987-02-20 |
| N83511S008 | NON-ABSORBABLE SUTURES NYLON | Davis & Geck, Inc. | 1987-02-20 |
| N85316S013 | ETHILON/NUROLON NYLON SUTURES | ETHICON, Inc. | 1986-12-03 |
| N83511S007 | NON-ABSORBABLE SUTURES NYLON | Davis & Geck, Inc. | 1986-11-17 |
| N83511S006 | NON-ABSORBABLE SUTURES NYLON | Davis & Geck, Inc. | 1986-09-30 |
| N80838S010 | SUPRAMID EXTRA SUTURES | S. Jackson, Inc. | 1986-08-05 |
| N85316S012 | ETHILON/NUROLON NYLON SUTURES | ETHICON, Inc. | 1986-06-20 |
| N80838S009 | SUPRAMID EXTRA SUTURES | S. Jackson, Inc. | 1985-07-23 |
| N80838S008 | SUPRAMID EXTRA SUTURES | S. Jackson, Inc. | 1985-05-17 |
| N80838S007 | SUPRAMID EXTRA SUTURES | S. Jackson, Inc. | 1985-02-28 |
| N85060S002 | NONABSORBABLE SURG. SUTURES, NYLON | Deknatel, Inc. | 1985-02-27 |
| N85316S011 | ETHILON/NUROLON NYLON SUTURES | ETHICON, Inc. | 1984-07-11 |
| N80838S006 | SUPRAMID EXTRA SUTURES | S. Jackson, Inc. | 1984-05-15 |
| N85316S010 | ETHILON/NUROLON NYLON SUTURES | ETHICON, Inc. | 1983-11-14 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220980 | Tissue Approximation System (TAS) | Tas Medical, Inc. | 2023-07-05 |
| K212888 | Golnit Nylon Monofilament Suture | Antarma, LLC Dba Golnit Sutures | 2022-03-31 |
| K212603 | Non Absorbable Surgical Nylon Suture | Shandong Haidike Medical Product Co., Ltd. | 2021-12-22 |
| K192420 | Crownjun Nylon Suture | Kono Seisakusho Co., Ltd. | 2020-05-29 |
| K161633 | REXLON, REXSIL | Sm Eng Co., Ltd. | 2017-03-02 |
| K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | Aesculap, Inc. | 2016-02-17 |
| K152795 | RiverLon (Nylon) Suture | Riverpoint Medical | 2015-10-28 |
| K123034 | VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED | Unilene Sac | 2013-05-28 |
| K081366 | KUMAR T-ANCHORS HERNIA SET | Nashville Surgical Instruments | 2008-07-15 |
| K060471 | FSSB NYLON SURGICAL SUTURES | Fssb Chirurgische Nadeln GmbH | 2006-07-26 |
| K053637 | MANI NEEDLE & SUTURE PACK (NYLON) | Mani, Inc. | 2006-05-19 |
| K060528 | AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE | Aesculap, Inc. | 2006-03-28 |
| K052900 | QUILL NONABSORBABLE NYLON BARBED SUTURE | Quill Medical, Inc. | 2005-11-28 |
| K052482 | ARTELON SURGICAL SUTURE | Artimplant AB | 2005-10-17 |
| K041510 | TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE | Sutures India Private Limited | 2005-06-02 |
| K042284 | UNIMIDE | United Medical Industries Co. , Ltd. | 2004-12-03 |
| K042367 | NYLON THREADED NEEDLE | Aros Surgical Instruments Corp. | 2004-10-14 |
| K032160 | ARTELON SURGICAL SUTURE | Artimplant AB | 2003-11-17 |
| K031531 | S&T MICROSURGICAL SUTURE | S & T AG | 2003-09-23 |
| K030177 | ORLON NONABSORABLE SURGICAL SUTURE USP | Sri Orion Pharmaceuticals & Sutures | 2003-07-21 |
| K023028 | DEMETECH NYLON NONABSORBABLE SUTURE | Demetech Corp. | 2003-06-18 |
| K024090 | NYLON SUTURE | Aurolab | 2003-02-28 |
| K020146 | SERRALNYL | Serral, S.A. DE C.V. | 2002-04-15 |
| K003000 | GRAMS NYLON NONABSORBABLE SUTURE | Gramsmed, LLC | 2000-12-18 |
| K001173 | NYLON, NONABSORBABLE SURGICAL SUTURES USP | Cp Medical | 2000-06-23 |
| K000539 | NYLON NONABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-27 |
| K993970 | MICRINS MICROSURGICAL SUTURE | Micrins Surgical, Inc. | 2000-03-30 |
| K994176 | SUTRALON NYLON SUTURES | Visionary Medical Supplies, Inc. | 2000-02-08 |
| K993998 | NYLON | Trading Consultants and Distributors Intl., Inc. | 2000-02-04 |
| K990090 | DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE | Aesculap, Inc. | 1999-03-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07757093013068 | SUTUMED | Unilene S.A.C. | 2023-01-06 |
| ESOT031940 | NA | S & T AG | 2016-09-24 |
| ESOT037020 | NA | S & T AG | 2016-09-24 |
| ESOT036990 | NA | S & T AG | 2016-09-24 |
| ESOT036980 | NA | S & T AG | 2016-09-24 |
| ESOT033950 | NA | S & T AG | 2016-09-24 |
| ESOT033920 | NA | S & T AG | 2016-09-24 |
| ESOT033890 | NA | S & T AG | 2016-09-24 |
| ESOT033880 | NA | S & T AG | 2016-09-24 |
| ESOT033860 | NA | S & T AG | 2016-09-24 |
| ESOT033850 | NA | S & T AG | 2016-09-24 |
| ESOT033830 | NA | S & T AG | 2016-09-24 |
| ESOT033820 | NA | S & T AG | 2016-09-24 |
| ESOT031990 | NA | S & T AG | 2016-09-24 |
| ESOT031950 | NA | S & T AG | 2016-09-24 |
| ESOT031480 | NA | S & T AG | 2016-09-24 |
| ESOT031920 | NA | S & T AG | 2016-09-24 |
| ESOT031910 | NA | S & T AG | 2016-09-24 |
| ESOT031890 | NA | S & T AG | 2016-09-24 |
| ESOT031880 | NA | S & T AG | 2016-09-24 |
| ESOT031860 | NA | S & T AG | 2016-09-24 |
| ESOT031840 | NA | S & T AG | 2016-09-24 |
| ESOT031800 | NA | S & T AG | 2016-09-24 |
| ESOT031790 | NA | S & T AG | 2016-09-24 |
| ESOT031770 | NA | S & T AG | 2016-09-24 |
| ESOT031760 | NA | S & T AG | 2016-09-24 |
| ESOT031740 | NA | S & T AG | 2016-09-24 |
| ESOT031710 | NA | S & T AG | 2016-09-24 |
| ESOT031700 | NA | S & T AG | 2016-09-24 |
| ESOT031670 | NA | S & T AG | 2016-09-24 |