Cleared Traditional

K940061 - POLYMEDIC SPINAL NEEDLE AND INTRODUCER

K940061 is an FDA 510(k) clearance for POLYMEDIC SPINAL NEEDLE AND INTRODUCER, manufactured by Techniques Medicales DE Navaree. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 714-day FDA review.

K940061 · Techniques Medicales DE Navaree · Anesthesiology device
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Dec 1995
Decision
714d
Days
Class 2
Risk

K940061 is an FDA 510(k) clearance for the POLYMEDIC SPINAL NEEDLE AND INTRODUCER. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Techniques Medicales DE Navaree (Washington, D.C., US). The FDA issued a Cleared decision on December 21, 1995 after a review of 714 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Techniques Medicales DE Navaree devices

FDA 510(k) Submission Details - K940061

510(k) Number K940061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1994
Decision Date December 21, 1995
Days to Decision 714 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
574d slower than avg
Panel avg: 140d · This submission: 714d
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 121
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K940061.
TUOHY EPIDURAL NEEDLES
K961152 · Hakko Shoji Co., Ltd. · Mar 1997
ANESTHESIA CONDUCTION NEEDLE
K962886 · Ispg, Inc. · Oct 1996
GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725)
K961444 · Global Medical Products, Ltd. · Aug 1996
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
MONOJECT TUOHY POINT EPIDURAL NEEDLE (22G X 3 1/2)
K951411 · Sherwood Medical Co. · May 1995