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 COVER, NON-STERILE

K-Number: K961342 · 1996-12-30

ApplicantCopioumed Intl., Inc.
Decision Date1996-12-30
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHOE COVER, NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Copioumed Intl., Inc.. It received FDA 510(k) clearance on 1996-12-30 under 510(k) number K961342. 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 COVER, NON-STERILE?

SHOE COVER, NON-STERILE is a medical device that received FDA 510(k) clearance on 1996-12-30. The listed applicant is Copioumed Intl., Inc.. The 510(k) number is K961342.

When did SHOE COVER, NON-STERILE receive FDA 510(k) clearance?

SHOE COVER, NON-STERILE received FDA 510(k) clearance on 1996-12-30, under 510(k) number K961342.

Who is the listed applicant for SHOE COVER, NON-STERILE?

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

What is the FDA product code for SHOE COVER, NON-STERILE?

The FDA product code for SHOE COVER, NON-STERILE 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 Copioumed Intl., 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.

K030927POWDERED VINYL EXAM GLOVES, WHITEK021961POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITEK021743(MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOWK972624POLY (VINYL) EXAM GLOVE, POWDER-FREEK971316POLY (VINYL) EXAM GLOVE, POWDEREDK965237NURSES BOUFFANT CAP

View all 8 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.K955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHInstrument Makar, Inc.K952937NIOMED NON-SKID SHOE COVERSAmerasia Corp.K952897NIOMED 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.

↑