Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VERSATILE 1 EZCARE WOUND VACUUM SYSTEM

K-Number: K061919 · 2007-02-05

ApplicantBlue Sky Medical Group Incorporated
Decision Date2007-02-05
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VERSATILE 1 EZCARE WOUND VACUUM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Blue Sky Medical Group Incorporated. It received FDA 510(k) clearance on 2007-02-05 under 510(k) number K061919. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSATILE 1 EZCARE WOUND VACUUM SYSTEM?

VERSATILE 1 EZCARE WOUND VACUUM SYSTEM is a medical device that received FDA 510(k) clearance on 2007-02-05. The listed applicant is Blue Sky Medical Group Incorporated. The 510(k) number is K061919.

When did VERSATILE 1 EZCARE WOUND VACUUM SYSTEM receive FDA 510(k) clearance?

VERSATILE 1 EZCARE WOUND VACUUM SYSTEM received FDA 510(k) clearance on 2007-02-05, under 510(k) number K061919.

Who is the listed applicant for VERSATILE 1 EZCARE WOUND VACUUM SYSTEM?

The FDA 510(k) record lists Blue Sky Medical Group Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERSATILE 1 EZCARE WOUND VACUUM SYSTEM?

The FDA product code for VERSATILE 1 EZCARE WOUND VACUUM SYSTEM is OMP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Blue Sky Medical Group Incorporated as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061367BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500K052456MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEMK042134VERSATILE 1 WOUND VACUUM SYSTEM

Related Devices (Code: OMP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork MedicalK254019Wound Geni NPWT SystemBechtel Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑