BSP · Class II · 21 CFR 868.5150

FDA Product Code BSP: Needle, Conduction, Anesthetic (w/wo Introducer)

Under FDA product code BSP, anesthetic conduction needles — with or without introducers — are cleared for regional anesthesia and nerve block procedures.

These specialized needles are designed to deposit local anesthetic adjacent to specific nerves or nerve plexuses, producing regional anesthesia for surgery or pain management. They are available in a range of gauges, lengths, and tip configurations optimized for different nerve block techniques.

BSP devices are Class II medical devices, regulated under 21 CFR 868.5150 and reviewed by the FDA Anesthesiology panel.

Leading manufacturers include PAJUNK GmbH Medizintechnologie, Pajunk GmbH and B.Braun Medical, Inc..

152
Total
152
Cleared
185d
Avg days
1981
Since
152 devices
49–72 of 152
Cleared Apr 16, 2010
CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680
K100241
B.Braun Medical, Inc.
Anesthesiology · 79d
Cleared Feb 26, 2010
FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE
K093209
Cook, Inc.
Anesthesiology · 136d
Cleared May 01, 2009
PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G
K090261
Smiths Medical Asd, Inc.
Anesthesiology · 87d
Cleared Jul 17, 2008
BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237
K081446
Becton, Dickinson & CO
Anesthesiology · 56d
Cleared Apr 09, 2008
MODIFICATION TO:SPECIALTY NEEDLES
K073222
Busse Hospital Disposables, Inc.
Anesthesiology · 146d
Cleared Feb 01, 2008
DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE
K063350
PAJUNK GmbH Medizintechnologie
Anesthesiology · 452d
Cleared Sep 06, 2006
SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)
K061394
Busse Hospital Disposables, Inc.
Anesthesiology · 110d
Cleared May 17, 2005
PROBLOC, HN SERIES AND PROLONG, PL SERIES
K050499
Life-Tech, Inc.
Anesthesiology · 78d
Cleared Apr 15, 2005
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE
K043500
Innospine, Inc.
Anesthesiology · 116d
Cleared Mar 31, 2005
FLEXIBLE SPINAL NEEDLE
K043467
Epimed International, Inc.
Anesthesiology · 106d
Cleared Dec 21, 2004
MODIFICATION TO: PLEXALONG SETS
K042979
Pajunk GmbH
Anesthesiology · 53d
Cleared Sep 07, 2004
PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES
K040965
Pajunk GmbH
Anesthesiology · 146d
Cleared Aug 24, 2004
PENCIL POINT NEEDLE
K041843
Epimed International, Inc.
Anesthesiology · 47d
Cleared May 27, 2003
WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
K030618
Wilson-Cook Medical, Inc.
Anesthesiology · 90d
Cleared Mar 24, 2003
MODIFICATION TO PLEXOLONG SETS
K023218
Pajunk GmbH
Anesthesiology · 179d
Cleared Jul 11, 2002
LUTZ NEEDLE
K013892
Ballard Medical Products
Anesthesiology · 230d
Cleared Jan 25, 2002
PERIFIX SAFETY EPIDURAL NEEDLES
K013610
B.Braun Medical, Inc.
Anesthesiology · 81d
Cleared Nov 16, 2001
BALLPEN SPINAL NEEDLE W/WO INTRODUCER
K011122
Rusch Intl.
Anesthesiology · 218d
Cleared Jun 26, 2001
MANAN SPRITACRE SPINAL NEEDLES
K011209
Manan Medical Products, Inc.
Anesthesiology · 68d
Cleared Jun 02, 2000
PHOENIX EPIDURAL & SPINAL NEEDLES
K990519
Myco Medical Supplies, Inc.
Anesthesiology · 470d
Cleared Apr 28, 2000
CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK
K993619
Sims Portex, Inc.
Anesthesiology · 185d
Cleared Mar 31, 2000
UNIPOLAR NEEDLES
K000722
Pajunk GmbH
Anesthesiology · 28d
Cleared Mar 28, 2000
BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES
K000495
Ballard Medical Products
Anesthesiology · 42d
Cleared Jan 08, 1999
MANAN SPINAL NEEDLES
K983620
Manan Medical Products, Inc.
Anesthesiology · 85d