Cleared Traditional

K080603 - HYBRID NERVE LOCATION NEEDLE COATED AND...

K080603 is an FDA 510(k) clearance for HYBRID NERVE LOCATION NEEDLE COATED AND..., manufactured by Te ME NA Sas. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K080603 · Te ME NA Sas · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Aug 2008
Decision
155d
Days
Class 2
Risk

K080603 is an FDA 510(k) clearance for the HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Te ME NA Sas (Appollo Beach, US). The FDA issued a Cleared decision on August 5, 2008 after a review of 155 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5150 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Te ME NA Sas devices

FDA 510(k) Submission Details - K080603

510(k) Number K080603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2008
Decision Date August 05, 2008
Days to Decision 155 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 140d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSP Device Classification - Class 2, Special Controls

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 85
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K080603.
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K081446 · Becton, Dickinson & CO · Jul 2008
MODIFICATION TO:SPECIALTY NEEDLES
K073222 · Busse Hospital Disposables, Inc. · Apr 2008
DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE
K063350 · PAJUNK GmbH Medizintechnologie · Feb 2008