Cleared Traditional

K853367 - H-H BURR HOLE CATHETER SUPPORT

K853367 is an FDA 510(k) clearance for H-H BURR HOLE CATHETER SUPPORT, manufactured by Holter-Hausner Intl.. The device is a Class 2 Neurology device with product code GXR cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K853367 · Holter-Hausner Intl. · Neurology device
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Sep 1985
Decision
21d
Days
Class 2
Risk

K853367 is an FDA 510(k) clearance for the H-H BURR HOLE CATHETER SUPPORT. Classified as Cover, Burr Hole (product code GXR), Class II - Special Controls.

Submitted by Holter-Hausner Intl. (Bridgeport, US). The FDA issued a Cleared decision on September 11, 1985 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5250 - 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 - K853367

510(k) Number K853367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1985
Decision Date September 11, 1985
Days to Decision 21 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
127d faster than avg
Panel avg: 148d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXR Device Classification - Class 2, Special Controls

Product Code GXR Cover, Burr Hole
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.