OMP
- 产品代码
- OMP
- 器械名称
- Negative Pressure Wound Therapy Powered Suction Pump
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 878.4780
- FDA 专业组
- General, Plastic Surgery
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 21 件
- 其中 Summary 已存档
- 19 份，可直接下载
- FDA 历史累计 510(k)
- 214 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
该代码近三年的 510(k)（21 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K253263 | 2026-06-24 | Convatec Limited, Gdc Building | ConvaVAC Negative Pressure Wound Therapy System | FDA |
| K253199 | 2026-06-23 | CG Bio Co., Ltd. | CURASYS 2 (EMDN0003) | |
| K260646 | 2026-05-27 | Smith & Nephew Medical, Ltd. | RENASYS EDGE (66803126) | |
| K261291 | 2026-05-21 | Cork Medical | Nisus NPWT Canister 500-mL (CPC-500) | |
| K254019 | 2026-05-04 | Bechtel Medical, Inc. | Wound Geni NPWT System | |
| K253429 | 2026-03-12 | Genadyne Biotechnologies, Inc. | Genadyne ASTRA NPWT | |
| K250586 | 2025-11-21 | Deroyal Industries, Inc. | Prospera Spectruum Negative Pressure Wound Therapy B… | |
| K251646 | 2025-10-03 | Alleva Medical Devices | extriCARE® 1000 Negative Pressure Wound Therapy Syst… | |
| K251826 | 2025-09-11 | Smith & Nephew Medical, Ltd. | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | |
| K243187 | 2025-06-27 | Cork Medical | Nisus ONE Negative Pressure Wound Therapy System (OC… | |
| K243576 | 2025-02-18 | Smith & Nephew Medical, Ltd. | RENASYS Foam Wound Dressing Kit with AIRLOCK Technol… | |
| K233614 | 2024-12-23 | Genadyne Biotechnologies, Inc. | Genadyne DUO NPWT | |
| K241061 | 2024-08-21 | Cork Medical | VERSA Negative Pressure Wound Therapy System (VCMPP-… | FDA |
| K241023 | 2024-08-19 | Med Way, Inc. | Negative Pressure Wound Therapy Device (V-Move, V-Gr… | |
| K241515 | 2024-07-26 | Nexa Medical Limited | NEXA NPWT System | |
| K231939 | 2024-05-24 | Smith & Nephew Medical, Ltd. | Renasys Edge | |
| K241134 | 2024-05-23 | Kci USA, Inc. | 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/… | |
| K230233 | 2024-04-18 | Deroyal Industries, Inc. | Prospera Spectruum Negative Pressure Wound Therapy S… | |
| K231646 | 2024-04-17 | Carilex Medical, Inc. | Carilex VT¿200-i NX | |
| K232379 | 2024-02-05 | Clear Choice Therapeutics | PREVENT Kit | |
| K230677 | 2023-12-06 | Cork Medical | Cork Medical VERSA Negative Pressure Wound System (V… |
FDA 官方分类页： OMP
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。