VERSATILE 1 EZCARE WOUND VACUUM SYSTEM— 510(k) K061919
Substantially EquivalentBlue Sky Medical Group Incorporated
FDA 510(k) clearance K061919 for VERSATILE 1 EZCARE WOUND VACUUM SYSTEM, Substantially Equivalent on 2007-02-05. Applicant: Blue Sky Medical Group Incorporated. Device class: 2.
Clearance details
- Applicant
- Blue Sky Medical Group Incorporated
- 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
- Carlsbad, CA, US
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 Blue Sky Medical Group Incorporated
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 →
Recalls naming K061919
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061919.
Data sourced from openFDA. This site is unofficial and independent of the FDA.