VERSATILE 1 EZCARE WOUND VACUUM SYSTEM— 510(k) K061919

Name: FDA 510(k) clearance K061919
Creator: U.S. Food and Drug Administration
Published: 2007-02-05

Substantially Equivalent

Blue 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: Code OMP
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2006-07-06
Decision date: 2007-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Blue Sky Medical Group Incorporated

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K061367 — BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.05002006-08-10
K052456 — MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM2005-11-04
K042134 — VERSATILE 1 WOUND VACUUM SYSTEM2004-11-01

Adverse 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, 2020-01-01 through 2026-04-23. 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 record

Z-2848-2016 — RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wounds types include chronic, acute, traumatic, Sub-Acute and dehisced wounds, ulcers, (such as pressure and diabetic), partial thickness burns, flaps and grafts.Class II·Ongoing·Smith & Nephew, Inc.·20160721

Matched 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.