Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4545](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4545) → GYK — Instrument, Shunt System Implantation

# GYK · Instrument, Shunt System Implantation

_Neurology · 21 CFR 882.4545 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK

## Overview

- **Product Code:** GYK
- **Device Name:** Instrument, Shunt System Implantation
- **Regulation:** [21 CFR 882.4545](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4545)
- **Device Class:** 1
- **Review Panel:** [Neurology](/submissions/NE)

## 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.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K962761](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK/K962761.md) | REIGEL TUNNELING DEVICE | Cook, Inc. | Oct 11, 1996 | SESE |
| [K934391](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK/K934391.md) | V/P AND L/P CATHETER PASSERS | Radionics, Inc. | Nov 19, 1993 | SESE |
| [K930606](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK/K930606.md) | PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER | Pudenz-Schulte Medical Research Corp. | Sep 10, 1993 | SESE |
| [K932273](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK/K932273.md) | CORDIS TUNNELER | Cordis Corp. | Aug 23, 1993 | SESE |
| [K895868](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK/K895868.md) | HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE | Baxter Healthcare Corp | Oct 31, 1989 | SESE |
| [K883607](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK/K883607.md) | PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER | Codman & Shurtleff, Inc. | Sep 30, 1988 | SESE |
| [K873771](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK/K873771.md) | HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO | American V. Mueller | Dec 18, 1987 | SESE |
| [K865075](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK/K865075.md) | H-H SUBGALEAL TROCAR | Holter-Hausner Intl. | Jan 13, 1987 | SESE |
| [K853370](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK/K853370.md) | H-H CATHETER PASSERS(TACL DESIGN | Holter-Hausner Intl. | Sep 18, 1985 | SESE |
| [K853368](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK/K853368.md) | H-H SHUNT INTRODUCER | Holter-Hausner Intl. | Sep 6, 1985 | SESE |
| [K841553](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK/K841553.md) | H-H SHUNT PASSERS | Holter-Hausner Intl. | May 14, 1984 | SESE |
| [K792639](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK/K792639.md) | H-H SHUNT INTRODUCER | Holter-Hausner Intl. | Dec 31, 1979 | SESE |
| [K771529](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK/K771529.md) | PERITONEAL INTRODUCER & SHEATH | Cordis Corp. | Aug 16, 1977 | SESE |

## Top Applicants

- Holter-Hausner Intl. — 5 clearances
- Cordis Corp. — 2 clearances
- American V. Mueller — 1 clearance
- Baxter Healthcare Corp — 1 clearance
- Codman & Shurtleff, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK)

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