Who is the manufacturer of REIGEL TUNNELING DEVICE?

Cook, Inc. filed the 510(k) submission for REIGEL TUNNELING DEVICE (K962761).

What is the FDA product code for REIGEL TUNNELING DEVICE?

GYK. It is classified under 21 CFR 882.4545 as a Class 1 device in the Neurology panel.

What is the regulatory pathway for REIGEL TUNNELING DEVICE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like REIGEL TUNNELING DEVICE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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.

Related Devices

K962097 — VENTRICULAR CATHETER SET · Cook, Inc. · Aug 29, 1996
K960915 — CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX · Clarus Medical Systems, Inc. · Dec 24, 1996
K102802 — INTEGRA ELECTRODE TUNNELING NEEDLE · Integra LifeSciences Corporation · Nov 23, 2010
K970658 — LUMBAR DRAINAGE ACCESSORY KIT · Integra Neurocare, LLC · May 19, 1997
K990333 — MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 · Medtronic PS Medical · Apr 28, 1999

Submission Summary (Full Text)

{0} 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 (812) 339-2235 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.