Nisus NPWT Canister 500-mL (CPC-500)— 510(k) K261291
Substantially EquivalentCork Medical
FDA 510(k) clearance K261291 for Nisus NPWT Canister 500-mL (CPC-500), Substantially Equivalent on 2026-05-21. Applicant: Cork Medical. Device class: 2.
Summary
Cork Medical's Nisus NPWT Canister 500-mL (CPC-500) is filed under OMP, negative pressure wound therapy powered suction pumps.
Class II, 21 CFR 878.4780. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Special 510(k).
Cork Medical filed from Indianapolis, Indiana. Review took 31 calendar days (April 20 to May 21, 2026).
Clearance details
- Applicant
- Cork Medical
- Product code
- Product code OMP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianapolis, IN, US
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More clearances from Cork Medical
view allAdverse events under product code OMP
product code OMP- Death
- 31
- Injury
- 1,707
- Malfunction
- 4,047
- Other
- 1
- Total
- 5,786
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.