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
73–96 of 152
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 Apr 22, 2004
SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09
K032981
Invamed Technologies, Inc.
Anesthesiology · 211d
Cleared May 27, 2003
WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
K030618
Wilson-Cook Medical, Inc.
Anesthesiology · 90d
Cleared Apr 03, 2003
TUOHY EPIDURAL NEEDLE
K030562
Epimed International, Inc.
Anesthesiology · 41d
Cleared Mar 24, 2003
MODIFICATION TO PLEXOLONG SETS
K023218
Pajunk GmbH
Anesthesiology · 179d
Cleared Oct 25, 2002
DR. JAPAN FACIL POINT SPINAL NEEDLE
K020934
Myco Medical, Inc.
Anesthesiology · 217d
Cleared Jul 30, 2002
QUINCKE SPINAL NEEDLE
K022029
Epimed International, Inc.
Anesthesiology · 39d
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 Dec 03, 2001
AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L
K013231
Avid N.I.T., Inc.
Anesthesiology · 67d
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 01, 2001
SPINAL EPIDURAL NEEDLES
K002405
Te ME NA S.A.R.L.
Anesthesiology · 298d
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
Cleared Jul 31, 1998
EPIDURAL NEEDLE
K980536
Manan Medical Products, Inc.
Anesthesiology · 170d
Cleared May 20, 1998
ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER
K972595
Avid N.I.T., Inc.
Anesthesiology · 313d
Cleared May 30, 1997
DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)
K951928
Csen , Ltd.
Anesthesiology · 766d
Cleared Mar 19, 1997
SPINAL NEEDLES
K961151
Hakko Shoji Co., Ltd.
Anesthesiology · 362d