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)

UNIPLAIN & UNICHROM

K-Number: K042287 · 2005-09-07

ApplicantUnited Medical Industries Co. , Ltd.
Decision Date2005-09-07
Product CodeGAL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNIPLAIN & UNICHROM is the device name listed in this FDA 510(k) record. The listed applicant is United Medical Industries Co. , Ltd.. It received FDA 510(k) clearance on 2005-09-07 under 510(k) number K042287. The device is classified under product code GAL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIPLAIN & UNICHROM?

UNIPLAIN & UNICHROM is a medical device that received FDA 510(k) clearance on 2005-09-07. The listed applicant is United Medical Industries Co. , Ltd.. The 510(k) number is K042287.

When did UNIPLAIN & UNICHROM receive FDA 510(k) clearance?

UNIPLAIN & UNICHROM received FDA 510(k) clearance on 2005-09-07, under 510(k) number K042287.

Who is the listed applicant for UNIPLAIN & UNICHROM?

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

What is the FDA product code for UNIPLAIN & UNICHROM?

The FDA product code for UNIPLAIN & UNICHROM is GAL.

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 United Medical Industries 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.

K072644UNICRYL QUICKK072646UNICAPRONEK072645UNIGLACTINK042288UNICRYLK042285UNICRYL MK042284UNIMIDE

View all 10 devices →

Related Devices (Code: GAL)

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.

K072930DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUTDemetech Corp.K042897AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGEEthicon Endo-Surgery, Inc.K030227SUTURTEK FASTCLOSE SUTURING DEVICESuturtek IncorporatedK020597SERRALGUTSerral, S.A. DE C.V.K021043GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMICGramsmed, LLCK011105SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICEQrc Consulting

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.

↑