Nisus NPWT Canister 500-mL (CPC-500)
FDA 510(k) K261291 · Cork Medical
510(k) numberK261291
Submission
- Device name
- Nisus NPWT Canister 500-mL (CPC-500)
- Applicant
- Cork Medical
Indianapolis, IN, US - Received
- April 20, 2026
- Decision date
- May 21, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K243187 | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)OMP · Traditional | Cork Medical | 06/27/2025SE |
More from Cork Medical
| 510(k) | Device | Decision |
|---|---|---|
| K243187 | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)OMP · Traditional | 06/27/2025SE |
| K241061 | VERSA Negative Pressure Wound Therapy System (VCMPP-100)OMP · Traditional | 08/21/2024SE |
| K230677 | Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)OMP · Traditional | 12/06/2023SE |
Questions and answers
When was Nisus NPWT Canister 500-mL (CPC-500) cleared by the FDA?
Nisus NPWT Canister 500-mL (CPC-500) (K261291) received a 510(k) decision of Substantially Equivalent on May 21, 2026, 31 days after the submission was received.
What is the product code of K261291?
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.