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FDA 510(k)

V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT

K-Number: K111280 · 2011-07-21

ApplicantKci USA, Inc.
Decision Date2011-07-21
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Kci USA, Inc.. It received FDA 510(k) clearance on 2011-07-21 under 510(k) number K111280. 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 V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT?

V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT is a medical device that received FDA 510(k) clearance on 2011-07-21. The listed applicant is Kci USA, Inc.. The 510(k) number is K111280.

When did V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT receive FDA 510(k) clearance?

V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT received FDA 510(k) clearance on 2011-07-21, under 510(k) number K111280.

Who is the listed applicant for V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT?

The FDA 510(k) record lists Kci USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT?

The FDA product code for V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT is OMP.

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Other records listing Kci USA, Inc. as applicant

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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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