GAR — Suture, Nonabsorbable, Synthetic, Polyamide Class II
FDA product code GAR covers "Suture, Nonabsorbable, Synthetic, Polyamide", a Class II medical device regulated under 21 CFR 878.5020. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GAR
- Device Class
- Class II
- Regulation Number
- 878.5020
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261484 | tas medical | Tissue Approximation System | June 3, 2026 |
| K220980 | tas medical | Tissue Approximation System (TAS) | July 5, 2023 |
| K212888 | antarma, llc dba golnit sutures | Golnit Nylon Monofilament Suture | March 31, 2022 |
| K212603 | shandong haidike medical product co | Non Absorbable Surgical Nylon Suture | December 22, 2021 |
| K192420 | kono seisakusho co | Crownjun Nylon Suture | May 29, 2020 |
| K161633 | sm eng co | REXLON, REXSIL | March 2, 2017 |
| K151165 | aesculap | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | February 17, 2016 |
| K152795 | riverpoint medical | RiverLon (Nylon) Suture | October 28, 2015 |
| K123034 | unilene sac | VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED | May 28, 2013 |
| K081366 | nashville surgical instruments | KUMAR T-ANCHORS HERNIA SET | July 15, 2008 |
| K060471 | fssb chirurgische nadeln | FSSB NYLON SURGICAL SUTURES | July 26, 2006 |
| K053637 | mani | MANI NEEDLE & SUTURE PACK (NYLON) | May 19, 2006 |
| K060528 | aesculap | AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE | March 28, 2006 |
| K052900 | quill medical | QUILL NONABSORBABLE NYLON BARBED SUTURE | November 28, 2005 |
| K052482 | artimplant | ARTELON SURGICAL SUTURE | October 17, 2005 |
| K041510 | sutures india private limited | TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE | June 2, 2005 |
| K042284 | united medical industries co. | UNIMIDE | December 3, 2004 |
| K042367 | aros surgical instruments | NYLON THREADED NEEDLE | October 14, 2004 |
| K032160 | artimplant | ARTELON SURGICAL SUTURE | November 17, 2003 |
| K031531 | s and t | S&T MICROSURGICAL SUTURE | September 23, 2003 |