Cleared Traditional

7D Surgical System Cranial Application (K181041) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181041 · 7D Surgical, Inc. · Neurology device
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Aug 2018
Decision
111d
Days
Class 2
Risk

K181041 is an FDA 510(k) clearance for the 7D Surgical System Cranial Application. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by 7D Surgical, Inc. (Toronto, CA). The FDA issued a Cleared decision on August 8, 2018 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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 7D Surgical, Inc. devices

Submission Details

510(k) Number K181041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2018
Decision Date August 08, 2018
Days to Decision 111 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
37d faster than avg
Panel avg: 148d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 - HAW Neurological Stereotaxic Instrument

All 163
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K181041.
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Voyager Trajectory Array Guide (V-TAG)
K180854 · Voyager Therapeutics, Inc. · Jul 2018
neuromate Gen III
K180206 · Renishaw Mayfield Sarl · Apr 2018