Cleared Traditional

K873771 - HEYER-SCHULTE ONE PIECE SHUNT VENT. CAT...

K873771 is the FDA 510(k) clearance for HEYER-SCHULTE ONE PIECE SHUNT VENT. CAT... by American V. Mueller. It is a Class 1 Neurology device (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

Submission Details

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
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 148d · This submission: 93d
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 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