Reigel Tunneling Device

Q: What is the product code of K962761?

The FDA product code is GYK – Instrument, Shunt System Implantation, a Class I (low risk) device regulated under 21 CFR 882.4545.

FDA 510(k) K962761 · Cook, Inc.

Substantially Equivalent

510(k) numberK962761

Submission

Device name: Reigel Tunneling Device
Applicant: Cook, Inc.
Bloomington, IN, US
Received: July 16, 1996
Decision date: October 11, 1996
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GYK – Instrument, Shunt System Implantation
Device class: Class I (low risk)
Regulation: 21 CFR 882.4545
Specialty: Neurology

Other 510(k)s with product code GYK

510(k)	Device	Applicant	Decision
K934391	V/P and L/P Catheter PassersGYK · Traditional	Radionics, Inc.	11/19/1993SE
K930606	PS Medical Disposable Subcutaneous Cath PasserGYK · Traditional	Pudenz-Schulte Medical Research Corp.	09/10/1993SE
K932273	Cordis TunnelerGYK · Traditional	Cordis Corp.	08/23/1993SE
K895868	Heyer-Schulte Disposable Peritoneal Catheter PasseGYK · Traditional	Baxter Healthcare Corp	10/31/1989SE
K883607	Peel-Away Introducer for Ventricular CatheterGYK · Traditional	Codman & Shurtleff, Inc.	09/30/1988SE
K873771	Heyer-Schulte(R) One Piece Shunt Vent. Cath. IntroGYK · Traditional	American V. Mueller	12/18/1987SE
K865075	H-H Subgaleal TrocarGYK · Traditional	Holter-Hausner Intl.	01/13/1987SE
K853370	H-H Catheter Passers(Tacl DesignGYK · Traditional	Holter-Hausner Intl.	09/18/1985SE
K853368	H-H Shunt IntroducerGYK · Traditional	Holter-Hausner Intl.	09/06/1985SE
K841553	H-H Shunt PassersGYK · Traditional	Holter-Hausner Intl.	05/14/1984SE

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Questions and answers

When was Reigel Tunneling Device cleared by the FDA?

Reigel Tunneling Device (K962761) received a 510(k) decision of Substantially Equivalent on October 11, 1996, 87 days after the submission was received.

What is the product code of K962761?

The FDA product code is GYK – Instrument, Shunt System Implantation, a Class I (low risk) device regulated under 21 CFR 882.4545.