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)

KOWA GENESIS-D

K-Number: K080681 · 2008-04-04

ApplicantKowa Co. , Ltd.
Decision Date2008-04-04
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KOWA GENESIS-D is the device name listed in this FDA 510(k) record. The listed applicant is Kowa Co. , Ltd.. It received FDA 510(k) clearance on 2008-04-04 under 510(k) number K080681. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOWA GENESIS-D?

KOWA GENESIS-D is a medical device that received FDA 510(k) clearance on 2008-04-04. The listed applicant is Kowa Co. , Ltd.. The 510(k) number is K080681.

When did KOWA GENESIS-D receive FDA 510(k) clearance?

KOWA GENESIS-D received FDA 510(k) clearance on 2008-04-04, under 510(k) number K080681.

Who is the listed applicant for KOWA GENESIS-D?

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

What is the FDA product code for KOWA GENESIS-D?

The FDA product code for KOWA GENESIS-D is HKI.

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 Kowa Co. , Ltd. 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.

K112330KOWA VX-20K101628KOWA NONMYD WXK091039KOWA, FM-600, MODEL LSS50K091098KOWAGENESIS-DFK091683KOWA VX-10 AK083387MODIFICATION TO KOWA NONMYD ALPHA-DIII

View all 15 devices →

Related Devices (Code: HKI)

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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, 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.

↑