Cleared Traditional

K951928 - DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)

K951928 is an FDA 510(k) clearance for DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE..., manufactured by Csen , Ltd.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 766-day FDA review.

K951928 · Csen , Ltd. · Anesthesiology device
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May 1997
Decision
766d
Days
Class 2
Risk

K951928 is an FDA 510(k) clearance for the DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE). Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Csen , Ltd. (Israel, IL). The FDA issued a Cleared decision on May 30, 1997 after a review of 766 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 Csen , Ltd. devices

FDA 510(k) Submission Details - K951928

510(k) Number K951928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1995
Decision Date May 30, 1997
Days to Decision 766 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
626d slower than avg
Panel avg: 140d · This submission: 766d
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 92
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K951928.
MANAN SPINAL NEEDLES
K983620 · Manan Medical Products, Inc. · Jan 1999
EPIDURAL NEEDLE
K980536 · Manan Medical Products, Inc. · Jul 1998
ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER
K972595 · Avid N.I.T., Inc. · May 1998
SPINAL NEEDLES
K961151 · Hakko Shoji Co., Ltd. · Mar 1997
TUOHY EPIDURAL NEEDLES
K961152 · Hakko Shoji Co., Ltd. · Mar 1997
ANESTHESIA CONDUCTION NEEDLE
K962886 · Ispg, Inc. · Oct 1996