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FDA 510(k)

MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM

K-Number: K052456 · 2005-11-04

ApplicantBlue Sky Medical Group Incorporated
Decision Date2005-11-04
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO VERSATILE 1 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 2005-11-04 under 510(k) number K052456. 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 MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM?

MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM is a medical device that received FDA 510(k) clearance on 2005-11-04. The listed applicant is Blue Sky Medical Group Incorporated. The 510(k) number is K052456.

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

MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM received FDA 510(k) clearance on 2005-11-04, under 510(k) number K052456.

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

The FDA product code for MODIFICATION TO VERSATILE 1 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.

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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.

K061919VERSATILE 1 EZCARE WOUND VACUUM SYSTEMK061367BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500K042134VERSATILE 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.

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