Cleared Traditional

HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO (K873771) - FDA 510(k) Clearance

Class I Neurology device.

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.