Cleared Traditional

K853368 - H-H SHUNT INTRODUCER

K853368 is an FDA 510(k) clearance for H-H SHUNT INTRODUCER, manufactured by Holter-Hausner Intl.. The device is a Class 1 Neurology device with product code GYK cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K853368 · Holter-Hausner Intl. · Neurology device
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Sep 1985
Decision
25d
Days
Class 1
Risk

K853368 is an FDA 510(k) clearance for the H-H SHUNT INTRODUCER. Classified as Instrument, Shunt System Implantation (product code GYK), Class I - General Controls.

Submitted by Holter-Hausner Intl. (Bridgeport, US). The FDA issued a Cleared decision on September 6, 1985 after a review of 25 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Holter-Hausner Intl. devices

FDA 510(k) Submission Details - K853368

510(k) Number K853368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date September 06, 1985
Days to Decision 25 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
123d faster than avg
Panel avg: 148d · This submission: 25d
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 K853368.
HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO
K873771 · American V. Mueller · Dec 1987
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 PASSERS
K841553 · Holter-Hausner Intl. · May 1984
H-H SHUNT INTRODUCER
K792639 · Holter-Hausner Intl. · Dec 1979
PERITONEAL INTRODUCER & SHEATH
K771529 · Cordis Corp. · Aug 1977