(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.
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510 (k) Premarket Notification Reigel Tunneling Device
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962761
I.510(K) SUMMARY
Submitted By:
April Lavender COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402 (812) 339-2235 July 12, 1996
Device:
| Trade Name: | Reigel Tunneling Device |
|---|---|
| Common/Usual Name: | Tunneler, Catheter Passer |
| Proposed Classification: | Shunt System Implantation Instrument21 CFR 882.4545 (84GYK), Class I |
OCT 11 1996
Predicate Devices:
The Reigel Tunneling Device is similar in terms of intended use, materials of construction, and technoloqical characteristics to predicate devices reviewed as instruments used to place cerebrospinal fluid shunt systems.
Device Description:
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.
Substantial Equivalence:
.
The device will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to devices currently manufactured and marketed by COOK INCORPORATED. This device is similar with respect to indications for use, materials and physical characteristics to predicate devices in terms of section 510(k) substantial equivalency.
§ 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.