Cleared Special

K121822 - DELICOT

K121822 is an FDA 510(k) clearance for DELICOT, manufactured by American Surgical Company, LLC. The device is a Class 2 Neurology device with product code HBA cleared through the Special 510(k) pathway after a 81-day FDA review.

K121822 · American Surgical Company, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K121822

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 149d · This submission: 81d
Pathway characteristics
Modification to existing cleared device.

HBA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HBA Neurosurgical Paddie

All 17
Devices cleared under the same product code (HBA) and FDA review panel - the closest regulatory comparables to K121822.
Codman Surgical Patties & Strips
K193346 · Integra LifeSciences Corporation · Nov 2020
MEDLINE NEURO SPONGE
K140369 · Medline Industries, Inc. · Sep 2014
AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)
K112598 · American Surgical Company, LLC · Jun 2013
NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES
K073576 · Harod Enterprises, Inc. · Feb 2008
AESCULAP NEURO PATTIES
K062406 · Aesculap, Inc. · Sep 2006
AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)
K031008 · Aesculap · May 2003
K121822 · DELICOT
Download PDF FDA Summary American Surgical Com…