Venturi Gauze Wound Care Sets with Portal Drain— 510(k) K151263
Substantially EquivalentTalley Group, Ltd.
FDA 510(k) clearance K151263 for Venturi Gauze Wound Care Sets with Portal Drain, Substantially Equivalent on 2016-02-19. Applicant: Talley Group, Ltd.. Device class: 2.
Clearance details
- Applicant
- Talley Group, 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
- Romsey, GB
Recent devices under product code OMP
view all- K260306 — RENASYS-G 15Fr Channel Drain Gauze Dressing Kit (66802257); RENASYS 15Fr Channel Drain Accessory Kit (66802253)
- K261982 — RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)
- K260426 — MeCare Alpha (MCA2019)
- K261338 — RENASYS DYNAFLOW Kit (66807741)
- K253263 — ConvaVAC Negative Pressure Wound Therapy System
More clearances from Talley Group, 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.