Cleared Traditional

K962761 - REIGEL TUNNELING DEVICE

K962761 is the FDA 510(k) clearance for REIGEL TUNNELING DEVICE by Cook, Inc.. It is a Class 1 Neurology device (product code GYK) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K962761 · Cook, Inc. · Neurology device

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Oct 1996

Decision

87d

Days

Class 1

Risk

K962761 is an FDA 510(k) clearance for the REIGEL TUNNELING DEVICE. Classified as Instrument, Shunt System Implantation (product code GYK), Class I - General Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on October 11, 1996 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4545 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook, Inc. devices

Submission Details

510(k) Number	K962761 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 16, 1996
Decision Date	October 11, 1996
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

61d faster than avg

Panel avg: 148d · This submission: 87d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	GYK Instrument, Shunt System Implantation
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 882.4545

What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GYK Instrument, Shunt System Implantation

All 11

Devices cleared under the same product code (GYK) and FDA review panel - the closest regulatory comparables to K962761.

V/P AND L/P CATHETER PASSERS

K934391 · Radionics, Inc. · Nov 1993

PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER

K930606 · Pudenz-Schulte Medical Research Corp. · Sep 1993

CORDIS TUNNELER

K932273 · Cordis Corp. · Aug 1993

HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE

K895868 · Baxter Healthcare Corp · Oct 1989

PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER

K883607 · Codman & Shurtleff, Inc. · Sep 1988

H-H SUBGALEAL TROCAR

K865075 · Holter-Hausner Intl. · Jan 1987

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K962761

Cook, Inc.

Bloomington, IN · US

APRIL LAVENDER

Regulatory profile

190 submissions 179 cleared

94% clearance rate · Active in Neurology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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