Cleared Traditional

K060097 - GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00

K060097 is an FDA 510(k) clearance for GROSSMAN SELF-RETAINING LOW PROFILE BRA..., manufactured by KLS-Martin L.P.. The device is a Class 2 Neurology device with product code GZT cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K060097 · KLS-Martin L.P. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
45d
Days
Class 2
Risk

K060097 is an FDA 510(k) clearance for the GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00. Classified as Retractor, Self-retaining, For Neurosurgery (product code GZT), Class II - Special Controls.

Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on February 27, 2006 after a review of 45 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 KLS-Martin L.P. devices

FDA 510(k) Submission Details - K060097

510(k) Number K060097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2006
Decision Date February 27, 2006
Days to Decision 45 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 148d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZT Device Classification - Class 2, Special Controls

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 28
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K060097.
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