(87 days)
The Reigel Tunneling Device is used for tunneling and passing shunt components under the skin for the placement of cerebrospinal fluid shunts from the head to the abdomen.
The Reigel Tunneling Device is used for tunneling and passing shunt components under the skin for the placement of cerebrospinal fluid shunts from the head to the abdomen. The device is supplied sterile. The materials comprising the device have an established history of use in medical product manufacturing.
This 510(k) Premarket Notification for the Reigel Tunneling Device does not contain any information about acceptance criteria or a study proving the device meets them.
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on intended use, materials, and technological characteristics. It is not a clinical study report or a performance evaluation.
Therefore, I cannot provide the requested information, as it is not present in the input text.
§ 882.4545 Shunt system implantation instrument.
(a)
Identification. A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.