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)

KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT

K-Number: K113199 · 2012-07-30

ApplicantKevo Medical Supplies
Decision Date2012-07-30
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Kevo Medical Supplies. It received FDA 510(k) clearance on 2012-07-30 under 510(k) number K113199. 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 KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT?

KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT is a medical device that received FDA 510(k) clearance on 2012-07-30. The listed applicant is Kevo Medical Supplies. The 510(k) number is K113199.

When did KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT receive FDA 510(k) clearance?

KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT received FDA 510(k) clearance on 2012-07-30, under 510(k) number K113199.

Who is the listed applicant for KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT?

The FDA 510(k) record lists Kevo Medical Supplies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT?

The FDA product code for KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT 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

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.

↑