Cleared Traditional

K043467 - FLEXIBLE SPINAL NEEDLE

K043467 is an FDA 510(k) clearance for FLEXIBLE SPINAL NEEDLE, manufactured by Epimed International, Inc.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K043467 · Epimed International, Inc. · Anesthesiology device
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Mar 2005
Decision
106d
Days
Class 2
Risk

K043467 is an FDA 510(k) clearance for the FLEXIBLE SPINAL NEEDLE. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Epimed International, Inc. (Johnstown, US). The FDA issued a Cleared decision on March 31, 2005 after a review of 106 days - within the typical 510(k) review window.

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 Epimed International, Inc. devices

FDA 510(k) Submission Details - K043467

510(k) Number K043467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2004
Decision Date March 31, 2005
Days to Decision 106 days
Submission Type Traditional
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
34d faster than avg
Panel avg: 140d · This submission: 106d
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 104
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K043467.
SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)
K061394 · Busse Hospital Disposables, Inc. · Sep 2006
PROBLOC, HN SERIES AND PROLONG, PL SERIES
K050499 · Life-Tech, Inc. · May 2005
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE
K043500 · Innospine, Inc. · Apr 2005
MODIFICATION TO: PLEXALONG SETS
K042979 · Pajunk GmbH · Dec 2004
PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES
K040965 · Pajunk GmbH · Sep 2004
PENCIL POINT NEEDLE
K041843 · Epimed International, Inc. · Aug 2004