3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit
FDA 510(k) K221585 · 3M Healthcare Business Group
Submission
- Device name
- 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit
- Applicant
- 3M Healthcare Business Group
San Antonio, TX, US - Received
- June 1, 2022
- Decision date
- March 23, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
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.
Other 510(k)s with product code OMP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261338 | RENASYS DYNAFLOW Kit (66807741)OMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2026SE |
| K253263 | ConvaVAC Negative Pressure Wound Therapy SystemOMP · Traditional | Convatec Limited, Gdc Building | 06/24/2026SE |
| K253199 | Curasys 2 (EMDN0003)OMP · Traditional | CG Bio Co., Ltd. | 06/23/2026SE |
| K260646 | Renasys Edge (66803126)OMP · Traditional | Smith & Nephew Medical, Ltd. | 05/27/2026SE |
| K261291 | Nisus NPWT Canister 500-mL (CPC-500)OMP · Special | Cork Medical | 05/21/2026SE |
| K254019 | Wound Geni NPWT SystemOMP · Traditional | Bechtel Medical, Inc. | 05/04/2026SE |
| K253429 | Genadyne ASTRA NPWTOMP · Traditional | Genadyne Biotechnologies, Inc. | 03/12/2026SE |
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam…OMP · Traditional | Deroyal Industries, Inc. | 11/21/2025SE |
| K251646 | extriCARE® 1000 Negative Pressure Wound Therapy SystemOMP · Traditional | Alleva Medical Devices | 10/03/2025SE |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologyOMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2025SE |
More from Smith & Nephew Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K220660 | Prevena Restor Adapti-Form DressingOMP · Traditional | 07/01/2022SE |
| K210135 | PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large DressingFRO · Traditional | 02/24/2022SE |
| K211521 | 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large…OMP · Traditional | 12/20/2021SE |
| K212320 | Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small…OMP · Traditional | 09/28/2021SE |
Questions and answers
When was 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit cleared by the FDA?
3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit (K221585) received a 510(k) decision of Substantially Equivalent on March 23, 2023, 295 days after the submission was received.
What is the product code of K221585?
The FDA product code is OMP – Negative Pressure Wound Therapy Powered Suction Pump, a Class II (moderate risk) device regulated under 21 CFR 878.4780.