REIGEL TUNNELING DEVICE

K962761 · Cook, Inc. · GYK · Oct 11, 1996 · Neurology

Device Facts

• Record ID: K962761
• Device Name: REIGEL TUNNELING DEVICE
• Applicant: Cook, Inc.
• Product Code: GYK · Neurology
• Decision Date: Oct 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4545
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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.

Device Story

Device used for subcutaneous tunneling; facilitates placement of cerebrospinal fluid (CSF) shunts from head to abdomen. Operated by neurosurgeons in clinical/OR settings. Manual instrument; passes shunt components under skin. Benefits patient by enabling minimally invasive shunt implantation. Sterile supply; established medical-grade materials.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual surgical instrument; stainless steel or medical-grade plastic construction; sterile; non-powered.

Indications for Use

Indicated for tunneling and passing shunt components subcutaneously during the placement of cerebrospinal fluid shunts from the head to the abdomen.

Regulatory Classification

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.

Submission Summary (Full Text)

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510(k) Premarket Notification
Reigel Tunneling Device

OCT 11 1996

K962761

I.510(K) SUMMARY

Submitted By:

April Lavender
COOK INCORPORATED
925 South Curry Pike
P.O. Box 489
Bloomington, IN 47402
[phone]
July 12, 1996

Device:

Trade Name: Reigel Tunneling Device

Common/Usual Name: Tunneler, Catheter Passer

Proposed Classification: Shunt System Implantation Instrument 21 CFR 882.4545 (84GYK), Class I

Predicate Devices:

The Reigel Tunneling Device is similar in terms of intended use, materials of construction, and technological 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.