Cleared Traditional

K865075 - H-H SUBGALEAL TROCAR

K865075 is an FDA 510(k) clearance for H-H SUBGALEAL TROCAR, 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 15-day FDA review.

K865075 · Holter-Hausner Intl. · Neurology device
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Jan 1987
Decision
15d
Days
Class 1
Risk

K865075 is an FDA 510(k) clearance for the H-H SUBGALEAL TROCAR. 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 January 13, 1987 after a review of 15 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 - K865075

510(k) Number K865075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1986
Decision Date January 13, 1987
Days to Decision 15 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
133d faster than avg
Panel avg: 148d · This submission: 15d
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 K865075.
HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE
K895868 · Baxter Healthcare Corp · Oct 1989
PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER
K883607 · Codman & Shurtleff, Inc. · Sep 1988
HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO
K873771 · American V. Mueller · Dec 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 PASSERS
K841553 · Holter-Hausner Intl. · May 1984