Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CM005 Standard (CM005); CM004 Mini (CM004)

K-Number: K233458 · 2024-07-15

ApplicantConnexicon Medical , Ltd.
Decision Date2024-07-15
Product CodeMPN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CM005 Standard (CM005); CM004 Mini (CM004) is a medical device manufactured by Connexicon Medical , Ltd.. It received FDA 510(k) clearance on 2024-07-15 under approval number K233458. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CM005 Standard (CM005); CM004 Mini (CM004)?

CM005 Standard (CM005); CM004 Mini (CM004) is a medical device that received FDA 510(k) clearance on 2024-07-15. It is manufactured by Connexicon Medical , Ltd.. The 510(k) number is K233458.

When was CM005 Standard (CM005); CM004 Mini (CM004) approved by the FDA?

CM005 Standard (CM005); CM004 Mini (CM004) received FDA 510(k) clearance on 2024-07-15, under approval number K233458.

What company makes CM005 Standard (CM005); CM004 Mini (CM004)?

CM005 Standard (CM005); CM004 Mini (CM004) is manufactured by Connexicon Medical , Ltd..

What is the FDA product code for CM005 Standard (CM005); CM004 Mini (CM004)?

The FDA product code for CM005 Standard (CM005); CM004 Mini (CM004) is MPN.

Other Devices by Connexicon Medical , Ltd.

K233460CM00622 LINC Skin Closure System (CM00622 LINC)

Related Devices (Code: MPN)

K162352derma+flex QS High Viscosity Tissue AdhesiveChemence Medical, Inc. K161011SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin AdhesiveAdhezion Biomedical, LLC K161050ACTABOND Topical Skin AdhesiveBergen Medical Products, Inc. K152476Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc. K150032GluStitch Twist Tissue AdhesiveGlustitch, Inc. K200264Exofin High Viscosity Topical Skin AdhesiveChemence Medical, 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.

↑