Cleared Traditional

DR. JAPAN FACIL POINT SPINAL NEEDLE (K020934) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K020934 · Myco Medical, Inc. · Anesthesiology device
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Oct 2002
Decision
217d
Days
Class 2
Risk

K020934 is an FDA 510(k) clearance for the DR. JAPAN FACIL POINT SPINAL NEEDLE. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Myco Medical, Inc. (Cary, US). The FDA issued a Cleared decision on October 25, 2002 after a review of 217 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 Myco Medical, Inc. devices

Submission Details

510(k) Number K020934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2002
Decision Date October 25, 2002
Days to Decision 217 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 140d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 44
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K020934.
FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE
K093209 · Cook, Inc. · Feb 2010
BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237
K081446 · Becton, Dickinson & CO · Jul 2008
WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
K030618 · Wilson-Cook Medical, Inc. · May 2003
PERIFIX SAFETY EPIDURAL NEEDLES
K013610 · B.Braun Medical, Inc. · Jan 2002
CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA.
K951949 · Baxter Healthcare Corp · Aug 1995
MONOJECT WHITACRE POINT SPINAL NEEDLE (27G X 3 1/2)
K951312 · Sherwood Medical Co. · May 1995