RENASYS DYNAFLOW Kit (66807741)— 510(k) K261338
Substantially EquivalentSmith & Nephew Medical, Ltd.
FDA 510(k) clearance K261338 for RENASYS DYNAFLOW Kit (66807741), Substantially Equivalent on 2026-09-11. Applicant: Smith & Nephew Medical, Ltd.. Device class: 2.
Summary
The RENASYS DYNAFLOW Kit (catalog 66807741) is part of Smith & Nephew's RENASYS negative pressure wound therapy line. It's filed under OMP, powered suction pumps for NPWT, so the clearance covers a kit configuration within that system.
Class II, 21 CFR 878.4780. The General and Plastic Surgery panel reviewed it as a Traditional 510(k).
Smith & Nephew Medical filed from Hull, England, its longtime UK wound care base. Review took 141 days (April 23 to September 11, 2026). Single-SKU kit clearances like this one usually add a configuration to a platform that's already on the market.
Clearance details
- Applicant
- Smith & Nephew Medical, Ltd.
- Product code
- 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
- Traditional
- Location
- Hull, GB
Recent devices under product code OMP
view allMore clearances from Smith & Nephew Medical, Ltd.
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.