Cleared Traditional

K895395 - V. MUELLER RHOTON SELF-RETAINING BRAIN ...

K895395 is the FDA 510(k) clearance for V. MUELLER RHOTON SELF-RETAINING BRAIN ... by Baxter Healthcare Corp. It is a Class 2 Neurology device (product code GZT) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K895395 · Baxter Healthcare Corp · Neurology device
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Oct 1989
Decision
48d
Days
Class 2
Risk

K895395 is an FDA 510(k) clearance for the V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR. Classified as Retractor, Self-retaining, For Neurosurgery (product code GZT), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Niles, US). The FDA issued a Cleared decision on October 19, 1989 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4800 - 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K895395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1989
Decision Date October 19, 1989
Days to Decision 48 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
100d faster than avg
Panel avg: 148d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZT Retractor, Self-retaining, For Neurosurgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4800
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.

Regulatory Peers - GZT Retractor, Self-retaining, For Neurosurgery

All 11
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K895395.
GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
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HARMONY PORT SYSTEM, MODEL 1907 SERIES
K050706 · Spinal Concepts, Inc. · Apr 2005
CODMAN LHALO SPLIT RING RETRACTOR SYSTEM
K913233 · Codman & Shurtleff, Inc. · Jul 1991
NEUROSURICAL RETRACTORS - VARIOUS TYPES
K892543 · Zinnanti Surgical Instruments, Inc. · May 1989
CYCLOPAC TENS
K801855 · Dow Corning Wright · Aug 1980