Cleared Traditional

K161004 - Self-retaining Retractor

K161004 is an FDA 510(k) clearance for Self-retaining Retractor, manufactured by Fetzer Medical GmbH & Co. KG. The device is a Class 2 Neurology device with product code GZT cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K161004 · Fetzer Medical GmbH & Co. KG · Neurology device
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Optimized for regulatory review, auditing and printing
Sep 2016
Decision
151d
Days
Class 2
Risk

K161004 is an FDA 510(k) clearance for the Self-retaining Retractor. Classified as Retractor, Self-retaining, For Neurosurgery (product code GZT), Class II - Special Controls.

Submitted by Fetzer Medical GmbH & Co. KG (Tuttlingen, DE). The FDA issued a Cleared decision on September 9, 2016 after a review of 151 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fetzer Medical GmbH & Co. KG devices

FDA 510(k) Submission Details - K161004

510(k) Number K161004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2016
Decision Date September 09, 2016
Days to Decision 151 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 148d · This submission: 151d
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 26
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K161004.
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SPOTLIGHT ACCESS SYSTEM
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SPOTLIGHT ACCESS SYSTEM
K112913 · Johnson & Johnson · Dec 2011