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K Number
K993424
Device Name
THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP
Manufacturer
Y-CLIP ASSOCIATES
Date Cleared
1999-12-23

(72 days)

Product Code
FZP
Regulation Number
878.4300
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This device is intended to be used for laproscopic and open surgical procedures to Ligate tissue and Blood vessels and Lymphatics

Device Description

Not Found

AI/ML Overview

This letter is a 510(k) clearance from the FDA, indicating that the device has been found substantially equivalent to a predicate device. It does not contain information about the device's acceptance criteria, performance studies, or details regarding the establishment of ground truth as typically found in a clinical study report or a more detailed regulatory submission.

Therefore, I cannot provide the requested information based on the given document. The document primarily focuses on regulatory clearance rather than scientific validation details.

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.