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510(k) Data Aggregation
K Number
K241595Device Name
EzVu Visual Vasopressor injector (EV-19)
Manufacturer
Veol Medical Technologies Pvt Ltd.
Date Cleared
2025-02-27
(269 days)
Product Code
FBK
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Veol Medical Technologies Pvt Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EzVu Visual Vasopressor Injector (EV-19) is intended to inject vasopressor solution into the uterine musculature during laparoscopic surgery.
Device Description
EzVu Visual Vasopressor Injector (EV-19) is a 330 mm long and 5 mm diameter hollow bore laparoscopic instrument, used to enable laparoscopic flashback visualization before injecting Vasopressor drug into the uterine musculature during laparoscopic surgery. It consists of a stainless steel needle at the distal end, securely connected to a hub, an elongated shaft with transparent window at the distal end and stopcock with luer connection at the proximal end onto which a syringe can be attached. The shaft is made of transparent plastic tube, surrounded by a stainless steel tube along the proximal portion of the injector to provide stability. The stainless steel tube around the transparent plastic tube is wrapped in a heat shrink. The injector is available in one needle size (19 gauge).
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K Number
K240205Device Name
Ez Catch Auto; Ez Catch YR; Ez Catch TR
Manufacturer
Veol Medical Technologies Pvt Ltd.
Date Cleared
2024-04-15
(81 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Veol Medical Technologies Pvt Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures.
Device Description
The EzCatch Tissue Retrieval Bag consists of a long cylindrical tube (Deployer Handpiece) and a polyurethane bag (Tissue Retrieval Bag) that minimizes spillage and intraoperative contamination by isolating and containing specimens. This device is designed for introduction and use through all appropriately sized trocar sleeve (of generally 10mm size). The EzCatch Tissue Retrieval Bag has application for safe, convenient removal of tissue specimens such as the appendix, an ectopic pregnancy, gallbladder, gallstones, lymph nodes, ovaries, small sections of bowel and other tissue structures.
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