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 (66807741) is from Smith & Nephew. It's filed under OMP, powered suction pumps for negative pressure wound therapy, a code for wound management by applying continual or intermittent negative pressure to remove fluids from the wound. The record doesn't list what the kit contains.
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, United Kingdom. Review took 141 days (April 23 to September 11, 2026).
Clearance details
- Applicant
- Smith & Nephew Medical, Ltd.
- 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
- Traditional
- Location
- Hull, GB
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- K261982 — RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)
- K260426 — MeCare Alpha (MCA2019)
- K253263 — ConvaVAC Negative Pressure Wound Therapy System
- K253199 — CURASYS 2 (EMDN0003)
More 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.