Cleared Traditional

K873771 - HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO

K873771 is an FDA 510(k) clearance for HEYER-SCHULTE ONE PIECE SHUNT VENT. CAT..., manufactured by American V. Mueller. The device is a Class 1 Neurology device with product code GYK cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K873771 · American V. Mueller · Neurology device
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Dec 1987
Decision
93d
Days
Class 1
Risk

K873771 is an FDA 510(k) clearance for the HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO. Classified as Instrument, Shunt System Implantation (product code GYK), Class I - General Controls.

Submitted by American V. Mueller (Chicago, US). The FDA issued a Cleared decision on December 18, 1987 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all American V. Mueller devices

FDA 510(k) Submission Details - K873771

510(k) Number K873771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1987
Decision Date December 18, 1987
Days to Decision 93 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 148d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

GYK Device Classification - Class 1, General Controls

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 12
Devices cleared under the same product code (GYK) and FDA review panel - the closest regulatory comparables to K873771.
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
H-H CATHETER PASSERS(TACL DESIGN
K853370 · Holter-Hausner Intl. · Sep 1985
H-H SHUNT INTRODUCER
K853368 · Holter-Hausner Intl. · Sep 1985