Cleared Traditional

K092973 - DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE

K092973 is an FDA 510(k) clearance for DISPOSABLE AND REUSABLE CONCENTRIC NEED..., manufactured by Bionen S.A.S.. The device is a Class 2 Neurology device with product code IKT cleared through the Traditional 510(k) pathway after a 377-day FDA review.

K092973 · Bionen S.A.S. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
377d
Days
Class 2
Risk

K092973 is an FDA 510(k) clearance for the DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLA.... Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Bionen S.A.S. (Carmel, US). The FDA issued a Cleared decision on October 7, 2010 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1385 - the FDA neurology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bionen S.A.S. devices

FDA 510(k) Submission Details - K092973

510(k) Number K092973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2009
Decision Date October 07, 2010
Days to Decision 377 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
229d slower than avg
Panel avg: 148d · This submission: 377d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKT Device Classification - Class 2, Special Controls

Product Code IKT Electrode, Needle, Diagnostic Electromyograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1385
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 - IKT Electrode, Needle, Diagnostic Electromyograph

All 25
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