Product Code: GYK FDA class 1 21 CFR 882.4545

Instrument, Shunt System Implantation

Neurology

The Shunt System Implantation Instrument is a surgical tool used to facilitate the precise placement of cerebrospinal fluid shunt components, such as ventricular catheters, during procedures to treat hydrocephalus or elevated intracranial pressure. It is classified as a Class 1 device (lowest risk), subject to general controls only, reflecting its role as a basic surgical aid rather than an active therapeutic device. The product code is GYK under regulation 21 CFR 882.4545 in the Neurology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.

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510(k)s

FEI Numbers

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Basic Information

Product Code: GYK
Device Class: FDA class 1
Regulation Number: 882.4545
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 13 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K962761	REIGEL TUNNELING DEVICE	Oct 11, 1996	Substantially Equivalent	Cook, Inc.
K934391	V/P AND L/P CATHETER PASSERS	Nov 19, 1993	Substantially Equivalent	Radionics, Inc.
K930606	PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER	Sep 10, 1993	Substantially Equivalent	Pudenz-Schulte Medical Research Corp.
K932273	CORDIS TUNNELER	Aug 23, 1993	Substantially Equivalent	Cordis Corp.
K895868	HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE	Oct 31, 1989	Substantially Equivalent	Baxter Healthcare Corp
K883607	PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER	Sep 30, 1988	Substantially Equivalent	Codman & Shurtleff, Inc.
K873771	HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO	Dec 18, 1987	Substantially Equivalent	American V. Mueller
K865075	H-H SUBGALEAL TROCAR	Jan 13, 1987	Substantially Equivalent	Holter-Hausner Intl.
K853370	H-H CATHETER PASSERS(TACL DESIGN	Sep 18, 1985	Substantially Equivalent	Holter-Hausner Intl.
K853368	H-H SHUNT INTRODUCER	Sep 06, 1985	Substantially Equivalent	Holter-Hausner Intl.
K841553	H-H SHUNT PASSERS	May 14, 1984	Substantially Equivalent	Holter-Hausner Intl.
K792639	H-H SHUNT INTRODUCER	Dec 31, 1979	Substantially Equivalent	Holter-Hausner Intl.
K771529	PERITONEAL INTRODUCER & SHEATH	Aug 16, 1977	Substantially Equivalent	Cordis Corp.