GAT
- 产品代码
- GAT
- 器械名称
- Suture, Nonabsorbable, Synthetic, Polyethylene
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 878.5000
- FDA 专业组
- General, Plastic Surgery
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 属植入器械
- 该代码近三年的 510(k)
- 176 件
该代码近三年的 510(k)（14 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K253910 | 2026-08-22 | GM Dos Reis Industria e Comercio Ltda. | Stitch - Suture Wires and Tapes 摘要 |
| K261021 | 2026-07-01 | Winter Innovations, Inc. | EasyWhip Family 摘要 |
| K260775 | 2026-05-06 | Teleflex Medical, LLC | Polyethylene;Polyethylene Fusion;Polyethylene OrthoT 摘要 |
| K254275 | 2026-03-23 | Threadstone, LLC | HyperSuture All Green Extension Line 摘要 |
| K254188 | 2026-02-19 | GM Dos Reis Industria e Comercio Ltda. | Meniscus Versaflex 摘要 |
| K253145 | 2025-10-22 | Rti Surgical, Inc. | Pre-Sutured Tendon 摘要 |
| K253024 | 2025-10-16 | Riverpoint Medical | ProZip Knotless Implant 摘要 |
| K252225 | 2025-09-12 | Medacta International S.A. | PowerKnot High Strength Sutures 摘要 |
| K252201 | 2025-08-13 | Riverpoint Medical | HS Fiber 摘要 |
| K242201 | 2025-03-27 | Threadstone, LLC | HyperSuture White/Green Extension Line 摘要 |
| K241376 | 2024-08-09 | Threadstone, LLC | HyperSuture All Blue Extension Line 摘要 |
| K234079 | 2024-05-10 | Threadstone, LLC | HyperSuture Extension Line 摘要 |
| K231163 | 2024-01-05 | Riverpoint Medical | HS Fiber Sutures 摘要 |
| K230311 | 2023-11-24 | Threadstone, LLC | HyperSuture 摘要 |
FDA 官方分类页： GAT
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。