FDA Product Code
FDA Product Code OMP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4780
510(k) Clearances — 215 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261338 | RENASYS DYNAFLOW Kit (66807741) | Smith & Nephew Medical, Ltd. | 2026-09-11 | Traditional | PDF ↗ |
| K253263 | ConvaVAC Negative Pressure Wound Therapy System | Convatec Limited, Gdc Building | 2026-06-24 | Traditional | PDF ↗ |
| K253199 | CURASYS 2 (EMDN0003) | CG Bio Co., Ltd. | 2026-06-23 | Traditional | PDF ↗ |
| K260646 | RENASYS EDGE (66803126) | Smith & Nephew Medical, Ltd. | 2026-05-27 | Traditional | PDF ↗ |
| K261291 | Nisus NPWT Canister 500-mL (CPC-500) | Cork Medical | 2026-05-21 | Special | PDF ↗ |
| K254019 | Wound Geni NPWT System | Bechtel Medical, Inc. | 2026-05-04 | Traditional | PDF ↗ |
| K253429 | Genadyne ASTRA NPWT | Genadyne Biotechnologies, Inc. | 2026-03-12 | Traditional | PDF ↗ |
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory | Deroyal Industries, Inc. | 2025-11-21 | Traditional | PDF ↗ |
| K251646 | extriCARE® 1000 Negative Pressure Wound Therapy System | Alleva Medical Devices | 2025-10-03 | Traditional | PDF ↗ |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | Smith & Nephew Medical, Ltd. | 2025-09-11 | Traditional | PDF ↗ |
| K243187 | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) | Cork Medical | 2025-06-27 | Traditional | PDF ↗ |
| K243576 | RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port | Smith & Nephew Medical, Ltd. | 2025-02-18 | Traditional | PDF ↗ |
| K233614 | Genadyne DUO NPWT | Genadyne Biotechnologies, Inc. | 2024-12-23 | Traditional | PDF ↗ |
| K241061 | VERSA Negative Pressure Wound Therapy System (VCMPP-100) | Cork Medical | 2024-08-21 | Traditional | PDF ↗ |
| K241023 | Negative Pressure Wound Therapy Device (V-Move, V-Grand) | Med Way, Inc. | 2024-08-19 | Traditional | PDF ↗ |
| K241515 | NEXA NPWT System | Nexa Medical Limited | 2024-07-26 | Traditional | PDF ↗ |
| K231939 | Renasys Edge | Smith & Nephew Medical, Ltd. | 2024-05-24 | Traditional | PDF ↗ |
| K241134 | 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10) | Kci USA, Inc. | 2024-05-23 | Special | PDF ↗ |
| K230233 | Prospera Spectruum Negative Pressure Wound Therapy System | Deroyal Industries, Inc. | 2024-04-18 | Traditional | PDF ↗ |
| K231646 | Carilex VT¿200-i NX | Carilex Medical, Inc. | 2024-04-17 | Traditional | PDF ↗ |
| K232379 | PREVENT Kit | Clear Choice Therapeutics | 2024-02-05 | Traditional | PDF ↗ |
| K230677 | Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) | Cork Medical | 2023-12-06 | Traditional | PDF ↗ |
| K223388 | Invia® Integrated Dressing | Medela AG | 2023-07-07 | Traditional | PDF ↗ |
| K221888 | Genadyne Hybrid Foam Dressings | Genadyne Biotechnologies, Inc. | 2023-06-12 | Traditional | PDF ↗ |
| K221585 | 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit | 3M Healthcare Business Group | 2023-03-23 | Traditional | PDF ↗ |
| K222859 | 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG) | 3M | 2023-03-23 | Traditional | PDF ↗ |
| K213906 | extriCARE 1000 Negative Pressure Wound Therapy System | Alleva Medical, Ltd. | 2023-03-08 | Traditional | PDF ↗ |
| K213853 | RENASYS-WF White Foam NPWT Dressing Small; RENASYS-WF White Foam NPWT Dressing Large | Smith and Nephew Medical Limited | 2023-02-10 | Traditional | PDF ↗ |
| K221223 | extriCARE® 3000 Negative Wound Pressure Therapy System | Alleva Medical Devices | 2023-02-09 | Traditional | PDF ↗ |
| K221891 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | 2022-12-14 | Special | PDF ↗ |
| K223041 | Renasys Edge (66803126) | Smith & Nephew Medical Limited | 2022-11-22 | Traditional | PDF ↗ |
| K212359 | PWD Negative Pressure Wound Therapy System | Applied Tissue Technologies, LLC | 2022-09-21 | Traditional | PDF ↗ |
| K214112 | Invia Ease Negative Pressure Wound Therapy (NPWT) System | Medela AG | 2022-07-26 | Traditional | PDF ↗ |
| K220560 | Dermatac Drape | 3M | 2022-07-14 | Traditional | PDF ↗ |
| K220660 | Prevena Restor Adapti-Form Dressing | 3M Healthcare Business Group | 2022-07-01 | Traditional | PDF ↗ |
| K210107 | Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | 2022-06-01 | Traditional | PDF ↗ |
| K211571 | Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit | Zhejiang Longterm Medical Technology Co., Ltd. | 2022-05-31 | Traditional | PDF ↗ |
| K202783 | Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing | Smith & Nephew Medical Limited | 2022-01-14 | Traditional | PDF ↗ |
| K211318 | PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs | Smith Nephew Medical Limited | 2022-01-05 | Traditional | PDF ↗ |
| K202898 | Tzoar 207 Negative Pressure Wound Therapy (NPWT) System | Lightstone Medical Products (Ningbo) Co, Ltd. | 2021-12-30 | Traditional | PDF ↗ |
| K211521 | 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG) | 3M Healthcare Business Group | 2021-12-20 | Traditional | PDF ↗ |
| K211277 | Theia NPWT Foam Wound Dressing Kit | Clear Choice Therapeutics, Inc. | 2021-12-16 | Traditional | PDF ↗ |
| K202823 | Innomed NPWT Silicone Foam Dressing | Zhejiang Longterm Medical Technology Co., Ltd. | 2021-12-15 | Traditional | PDF ↗ |
| K203316 | V.A.C.ULTA Negative Pressure Wound Therapy System | Kci, A Part of 3M Health Care Business Group | 2021-10-27 | Traditional | PDF ↗ |
| K212320 | Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac | 3M Healthcare Business Group | 2021-09-28 | Traditional | PDF ↗ |
| K203693 | Nisus Touch Negative Pressure Wound Therapy Pump | Cork Medical Products, LLC | 2021-08-13 | Traditional | PDF ↗ |
| K203369 | Avance Solo Negative Pressure Wound Therapy (NPWT) System | Molnlycke Health Care Us, LLC | 2021-07-01 | Traditional | PDF ↗ |
| K202217 | Kendall NPWT Incision Management Device | Cardinalhealth | 2021-06-04 | Traditional | PDF ↗ |
| K202157 | PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack | Smith & Nephew Medical Limited | 2020-10-30 | Traditional | PDF ↗ |
| K200223 | PocketDoc Micro Wound Therapy System | Pensar Medical, LLC | 2020-10-23 | Traditional | PDF ↗ |
| K191101 | Kendall NPWT Incision Management Dressing Kit | Cardinalhealth | 2020-07-31 | Traditional | PDF ↗ |
| K201571 | ACTIV.A.C. Negative Pressure Wound Therapy System | Kci USA, Inc. | 2020-07-08 | Special | PDF ↗ |
| K200390 | V.A.C. DERMATAC Drape | Kci USA, Inc. | 2020-05-18 | Traditional | PDF ↗ |
| K190028 | UNO 30 | Genadyne Biotechnologies | 2020-01-15 | Traditional | PDF ↗ |
| K191760 | PICO 14 Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2019-12-05 | Traditional | PDF ↗ |
| K190697 | PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag) | Kci USA, Inc. | 2019-11-22 | Traditional | PDF ↗ |
| K190119 | Foryou NPWT Dressing Kit | 4l Health Co., Ltd. | 2019-11-01 | Traditional | PDF ↗ |
| K182722 | XLR8 Abdominal Wound Dressing Kit | Genadyne Biotechnologies | 2019-09-27 | Traditional | PDF ↗ |
| K191460 | PWD Platform Wound Dressing 3 x 5 Oblong | Applied Tissue Technologies, LLC | 2019-07-02 | Special | PDF ↗ |
| K182458 | Longterm NPWT Foam Dressing Kit | Zhejiang Longterm Medical Technology Co., Ltd. | 2019-05-23 | Traditional | PDF ↗ |
| K181505 | V.A.C. DERMATAC Drape | Kci USA, Inc. | 2019-03-28 | Traditional | PDF ↗ |
| K181929 | MiMo(TM) Negative Pressure Wound Therapy System | Baymax Research, Inc. | 2019-03-27 | Traditional | PDF ↗ |
| K181822 | RENASYS Touch; RENASYS Y-Connector | Smith & Nephew Medical Limited | 2019-03-21 | Traditional | PDF ↗ |
| K183543 | ACTIV.A.C. Therapy Unit | Kci USA, Inc. | 2019-03-20 | Traditional | PDF ↗ |
| K181507 | PREVENA RESTOR(TM) Incision Management System | Kci USA, Inc. | 2019-02-15 | Traditional | PDF ↗ |
| K182191 | Invia Abdominal Dressing Kit | Medela AG | 2019-02-01 | Traditional | PDF ↗ |
| K182323 | PICO 7Y Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2019-01-18 | Traditional | PDF ↗ |
| K182409 | Applied Tissue Technologies PWD Platform Wound Dressing | Applied Tissue Technologies, LLC | 2019-01-11 | Traditional | PDF ↗ |
| K181204 | RENASYS Y-Connector; RENASYS TOUCH | Smith & Nephew Medical Limited | 2019-01-10 | Traditional | PDF ↗ |
| K180840 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | 2018-11-30 | Traditional | PDF ↗ |
| K180415 | Invia White Foam NPWT | Medela AG | 2018-11-02 | Traditional | PDF ↗ |
| K180205 | AVELLE Negative Pressure Wound Therapy System | Convatec Limited | 2018-10-19 | Traditional | PDF ↗ |
| K180698 | PICO 7 Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2018-08-21 | Traditional | PDF ↗ |
| K173407 | VT - 100, VT - 200 | Carilex Medical, Inc. | 2018-08-09 | Traditional | PDF ↗ |
| K172725 | VT Dressing Kits | Carilex Medical, Inc. | 2018-06-08 | Traditional | PDF ↗ |
| K180855 | Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System | Kci USA, Inc. | 2018-06-01 | Traditional | PDF ↗ |
| K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion 120 days, Invia Motion 60 days, Invia Motion 30 days, Invia Motion 15 days, Invia Motion 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad | Medela AG | 2018-05-09 | Traditional | PDF ↗ |
| K180618 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2018-04-20 | Special | PDF ↗ |
| K180614 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2018-04-06 | Special | PDF ↗ |
| K173426 | PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System | Kci USA, Inc. | 2018-03-09 | Traditional | PDF ↗ |
| K173447 | V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit | Kci USA, Inc. | 2018-03-02 | Traditional | PDF ↗ |
| K172005 | PICO 7 Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2018-02-02 | Traditional | PDF ↗ |
| K171499 | Occlusion Detection Dressing Kit | Cardinalhealth | 2017-09-22 | Traditional | PDF ↗ |
| K172521 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2017-09-20 | Special | PDF ↗ |
| K172519 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2017-09-15 | Special | PDF ↗ |
| K162610 | NEXA Negative Pressure Wound Therapy System | Nexa Medical , Ltd. | 2017-06-08 | Traditional | PDF ↗ |
| K162159 | VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing | Vr Medical Technologies, LLC | 2017-04-28 | Traditional | PDF ↗ |
| K163387 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2017-04-18 | Traditional | PDF ↗ |
| K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film | Medela AG | 2017-04-06 | Traditional | PDF ↗ |
| K161599 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | 2017-04-06 | Traditional | PDF ↗ |
| K161432 | MyNeWT Negative Pressure Wound Therapy System | Stortford Medical, LLC | 2017-02-08 | Traditional | PDF ↗ |
| K162790 | V.A.C.ULTA Negative Pressure Wound Therapy System | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2017-01-26 | Traditional | PDF ↗ |
| K161418 | Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set | Cardinalhealth | 2017-01-19 | Traditional | PDF ↗ |
| K160487 | V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System | Kci USA, Inc. | 2016-12-09 | Traditional | PDF ↗ |
| K150960 | WoundPro Negative Pressure Wound Therapy System | Pensar Medical, LLC | 2016-12-01 | Traditional | PDF ↗ |
| K161128 | Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply | Medela AG | 2016-12-01 | Traditional | PDF ↗ |
| K161935 | Avance Foam Dressing Kit - XL | Molnlycke Health Care Us, LLC | 2016-11-04 | Traditional | PDF ↗ |
| K161948 | Avance Gauze Dressing Kits | Molnlycke Health Care Us, LLC | 2016-11-03 | Traditional | PDF ↗ |
| K161797 | Avance Tubing, Avance Y-Connector, Avance ViewPad | Molnlycke Health Care Us, LLC | 2016-10-19 | Traditional | PDF ↗ |
| K161410 | VT·One, VT·One 60days | Carilex Medical, Inc. | 2016-10-13 | Traditional | PDF ↗ |
Product code OMP · Class II · General, Plastic Surgery. Data: openFDA.