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)

SHOE COVERS

K-Number: K844705 · 1985-01-10

ApplicantMedicon, Inc.
Decision Date1985-01-10
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHOE COVERS is the device name listed in this FDA 510(k) record. The listed applicant is Medicon, Inc.. It received FDA 510(k) clearance on 1985-01-10 under 510(k) number K844705. The device is classified under product code FXP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHOE COVERS?

SHOE COVERS is a medical device that received FDA 510(k) clearance on 1985-01-10. The listed applicant is Medicon, Inc.. The 510(k) number is K844705.

When did SHOE COVERS receive FDA 510(k) clearance?

SHOE COVERS received FDA 510(k) clearance on 1985-01-10, under 510(k) number K844705.

Who is the listed applicant for SHOE COVERS?

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

What is the FDA product code for SHOE COVERS?

The FDA product code for SHOE COVERS is FXP.

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 Medicon, Inc. 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.

K962087SERVOTRONIC EC100 SYSTEMK952168TITANIUM MANDIBULAR FRACTURE SYSTEMK850855TENS GB1001 DEVICEK850852INFRARAX DEVICEK844702GAUZE ASORBABLEK844573ABSORBABLE GAUZE PRODUCTS

View all 14 devices →

Related Devices (Code: FXP)

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.

K971076PRIMED SHOE COVERS, PRIMED HEAD COVERSPrimeline Medical Products, Inc.K971191FAR-EAST SHOE COVERSFar East Science & Technology Development Co., Ltd.K970815CONVERTORS IMPERVIOUS SHOE COVERSAllegiance Healthcare Corp.K961342SHOE COVER, NON-STERILECopioumed Intl., Inc.K955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHInstrument Makar, Inc.K952937NIOMED NON-SKID SHOE COVERSAmerasia Corp.

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.

↑