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VOMED urethra olives are acorn-tipped reusable devices designed for use in ureterography. With the aid of a ureterocystoscope, a radiopaque medium is injected into the ureter for radiologic imaging.

The VOMED urethra olives are accessories of male urethrographic catheters. They are placed temporarily on the external end of the penis to guide the insertion of the catheters and to facilitate the injection of the opaque substance.

The devices are indicated for diagnostic and therapeutic urologic procedures.

VOMED urethra olives are acorn-tipped reusable devices designed for use in ureterography. They are accessories of male urethrographic catheters.

The provided text is a 510(k) summary for VOMED Urethra Olive Models. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document is a letter from the FDA determining substantial equivalence for the specified device. It focuses on regulatory aspects such as classification, general controls, and compliance with the Federal Food, Drug, and Cosmetic Act. It also includes the official "Indications for Use" for the VOMED Urethra Olives.

Therefore, I cannot extract the requested information from the provided text.

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VOMED trocars are intended to provide access to the thoracic cavity through ports in the intercostal spaces, with minimal to no rib retraction. VOMED trocars and trocar sleeves then allow endoscopic instruments, thoracoscopes, laparoscopes, a tube or a channel, and accessory devices to be inserted and used during cardiac surgery procedures.

VOMED adapters, tube connectors, caps and plugs, stopcocks and valves are noninvasive, reusable devices for use in cardiovascular applications to interconnect tubing and other devices during extracorporeal bypass procedures, effectively establishing a conduit between the devices for the flow of blood and other extracorporeal fluids.

VOMED Trocars and Adapters, Connectors, Stopcocks and Manifolds

I am sorry, but the provided text is a letter from the FDA to VOMED Volzer Medizintechnik GmbH & Co. regarding the clearance of their Trocars and Adapters, Connectors, Stopcocks and Manifolds. This document does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. It is a regulatory clearance letter, not a study report.

Therefore, I cannot extract the requested information from the given text.

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VOMED insufflation needles are reusable devices for temporary use in conjunction with FDA-cleared insufflators to blow gas or powder into a tube, cavity, or organ. They are generally used as accessories to devices that provide access, illumination and visualization of internal structures and for manipulating soft tissuc. The devices are indicated for therapeutic and diagnostic laparoscopic and urological procedures.

VOMED suction and irrigation tubes and handles are reusable accessories designed for the suction of fluids from wounds and body cavities and/or the irrigation of surgical sites. They are general accessories of devices that provide access, illumination and visualization of internal structures and for manipulating soft tissue. The suction and irrigation devices are indicated for therapeutic laparoscopic and urologic procedures.

VOMED insufflation needles are reusable devices for temporary use in conjunction with FDA-cleared insufflators. VOMED suction and irrigation tubes and handles are reusable accessories.

The provided document is a 510(k) premarket notification letter from the FDA to VOMED Volzer Medizintechnik GmbH & Co. concerning their Endoscopic and Urologic Accessories, specifically VOMED Insufflation Needles and VOMED Suction & Irrigation Devices. This type of document declares substantial equivalence to a predicate device, allowing the device to be marketed.

Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The letter focuses on regulatory approval based on substantial equivalence, meaning the device is considered as safe and effective as a legally marketed predicate device. This typically involves demonstrating that the new device has the same intended use, technological characteristics, and performance characteristics (if applicable) as the predicate.

Therefore, I cannot provide the requested information from this document. The document primarily serves as an FDA clearance letter and does not detail the technical studies that would typically lead to acceptance criteria and performance data.

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