LogoFDA 510(k) Search
K Number
K024372
Device Name
CP MEDICAL BONE WAX
Manufacturer
CP MEDICAL
Date Cleared
2003-06-19

(170 days)

Product Code
MTJ
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K791495,K971680
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The CP Medical Bone Wax is indicated for use in the control of bleeding from bone surfaces.

Device Description

The proposed device is composed of a beeswax and paraffin formulation.
The proposed device is manufactured in compliance with cGMP and ISO quality standards.

AI/ML Overview

This submission K024372 is for a medical device (Bone Wax) and does not contain information related to AI/ML software. Therefore, none of the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is applicable or available in the provided text. The submission focuses on substantial equivalence to predicate devices based on composition and manufacturing standards, not on performance metrics of an AI algorithm.

N/A