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510(k) Data Aggregation
K Number
K042287Device Name
UNIPLAIN & UNICHROMManufacturer
Date Cleared
2005-09-07
(379 days)
Product Code
Regulation Number
878.4830Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
UNIPLAIN & UNICHROM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
UniPlain & UniChrom are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular procedures and neurological procedures.
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text is a 510(k) clearance letter for a medical device (surgical sutures) and does not contain any information about acceptance criteria, study details, or performance data for an AI/ML device. Therefore, I cannot generate the requested table and accompanying details based on the given input.
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