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)

EPIFLO(R)

K-Number: K120764 · 2012-04-27

ApplicantNeogenix, LLC
Decision Date2012-04-27
Product CodeKPJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPIFLO(R) is the device name listed in this FDA 510(k) record. The listed applicant is Neogenix, LLC. It received FDA 510(k) clearance on 2012-04-27 under 510(k) number K120764. The device is classified under product code KPJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPIFLO(R)?

EPIFLO(R) is a medical device that received FDA 510(k) clearance on 2012-04-27. The listed applicant is Neogenix, LLC. The 510(k) number is K120764.

When did EPIFLO(R) receive FDA 510(k) clearance?

EPIFLO(R) received FDA 510(k) clearance on 2012-04-27, under 510(k) number K120764.

Who is the listed applicant for EPIFLO(R)?

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

What is the FDA product code for EPIFLO(R)?

The FDA product code for EPIFLO(R) is KPJ.

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: KPJ)

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.

K250188Wound Treatment System (VHT-200)Vaporox, Inc.K212121VHT-200 Wound Treatment SystemVaporox, Inc.K190742EPIFLO-28Neogenix, LLC Dba OgenixK112634NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODPInotec Amd , Ltd.K090681TANSCU O2Electrochemical Oxygen Concepts, Inc.K080966HYPER-BOX TOPICAL WOUND OXYGEN SYSTEMAoti , Ltd.

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.

↑