Cleared Special

K101728 - FOCUS (TM) ECHOGENIC NERVE STIMULATING ...

K101728 is the FDA 510(k) clearance for FOCUS (TM) ECHOGENIC NERVE STIMULATING ... by Cook, Inc.. It is a Class 2 Anesthesiology device (product code BSP) cleared through the Special 510(k) pathway after a 65-day FDA review.

K101728 · Cook, Inc. · Anesthesiology device
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Aug 2010
Decision
65d
Days
Class 2
Risk

K101728 is an FDA 510(k) clearance for the FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on August 25, 2010 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5150 - the FDA anesthesiology and respiratory 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.

View all Cook, Inc. devices

Submission Details

510(k) Number K101728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2010
Decision Date August 25, 2010
Days to Decision 65 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 140d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code BSP Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5150
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BSP Needle, Conduction, Anesthetic (w/wo Introducer)

All 64
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K101728.
PENCAN SPINAL NEEDLE
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K111374 · PAJUNK GmbH Medizintechnologie · Aug 2011
MEDLINE EPIDURAL AND SPINAL NEEDLES
K110194 · Medline Industries, Inc. · Jun 2011
CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680
K100241 · B.Braun Medical, Inc. · Apr 2010
FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE
K093209 · Cook, Inc. · Feb 2010
PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G
K090261 · Smiths Medical Asd, Inc. · May 2009