Cleared Special

K112598 - AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) (FDA 510(k) Clearance)

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

K112598 · American Surgical Company, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
652d
Days
Class 2
Risk

K112598 is an FDA 510(k) clearance for the AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND). 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 June 20, 2013 after a review of 652 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all American Surgical Company, LLC devices

Submission Details

510(k) Number K112598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2011
Decision Date June 20, 2013
Days to Decision 652 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
504d slower than avg
Panel avg: 148d · This submission: 652d
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.