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510(k) Data Aggregation
K Number
K233772Device Name
Disposable Dual Action Tissue Closure Device
Manufacturer
Mirco-Tech (Nanjing) Co., Ltd.
Date Cleared
2024-03-19
(116 days)
Product Code
PKL
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
Mirco-Tech (Nanjing) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Dual Action Tissue Closure Device is intended for use in flexible endoscopy for the compression of tissue in the gastrointestinal tract for adult patient only.
The Disposable Dual Action Tissue Closure Device is indicated for clip placement within the gastrointestinal tract for the purpose of:
1. Endoscopic marking:
2. Hemostasis for:
a.Mucosal/sub-mucosal defects < 5 cm,
b.Bleeding ulcers,
c.Polyps < 1.5 cm in diameter,
d.Diverticula in the colon,
e. Arteries < 2 mm,
3. As a supplementary method. closure of GI tract luminal perforations < 20 mm that can be treated conservatively.
Device Description
The proposed device Disposable Dual Action Tissue Closure Device is a sterile, single-use endoscopic clipping device, intended to be used in flexible endoscopy for the compression, manipulation of tissue in the gastrointestinal tract. It consists of two main components, delivery system and clip assembly. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 3 years.
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