RENASYS EDGE (66803126)— 510(k) K260646
Substantially EquivalentSmith & Nephew Medical, Ltd.
FDA 510(k) clearance K260646 for RENASYS EDGE (66803126), Substantially Equivalent on 2026-05-27. Applicant: Smith & Nephew Medical, Ltd.. Device class: 2.
Summary
Smith & Nephew Medical's RENASYS EDGE (66803126) 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 the submission was a Traditional 510(k).
Smith & Nephew filed from Hull, United Kingdom. Review took 89 calendar days (February 27 to May 27, 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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- K260426 — MeCare Alpha (MCA2019)
- K261338 — RENASYS DYNAFLOW Kit (66807741)
- K253263 — ConvaVAC Negative Pressure Wound Therapy System
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.