Cleared Special

K121822 - DELICOT (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K121822 · American Surgical Company, LLC · Neurology device
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Optimized for regulatory review, auditing and printing
Sep 2012
Decision
81d
Days
Class 2
Risk

K121822 is an FDA 510(k) clearance for the DELICOT. Classified as Neurosurgical Paddie (product code HBA), Class II - Special Controls.

Submitted by American Surgical Company, LLC (Lynn, US). The FDA issued a Cleared decision on September 10, 2012 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4700 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K121822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2012
Decision Date September 10, 2012
Days to Decision 81 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 148d · This submission: 81d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HBA Neurosurgical Paddie
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4700
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.