Cleared Traditional

K841553 - H-H SHUNT PASSERS

K841553 is an FDA 510(k) clearance for H-H SHUNT PASSERS, 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 28-day FDA review.

K841553 · Holter-Hausner Intl. · Neurology device
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May 1984
Decision
28d
Days
Class 1
Risk

K841553 is an FDA 510(k) clearance for the H-H SHUNT PASSERS. Classified as Instrument, Shunt System Implantation (product code GYK), Class I - General Controls.

Submitted by Holter-Hausner Intl. (Mchenry, US). The FDA issued a Cleared decision on May 14, 1984 after a review of 28 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 - K841553

510(k) Number K841553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1984
Decision Date May 14, 1984
Days to Decision 28 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
120d faster than avg
Panel avg: 148d · This submission: 28d
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 K841553.
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
H-H SHUNT INTRODUCER
K792639 · Holter-Hausner Intl. · Dec 1979
PERITONEAL INTRODUCER & SHEATH
K771529 · Cordis Corp. · Aug 1977