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 Holgrath Medical Technologies, Inc..

152
Total
152
Cleared
185d
Avg days
1981
Since
152 devices
97–120 of 152
Cleared Mar 19, 1997
TUOHY EPIDURAL NEEDLES
K961152
Hakko Shoji Co., Ltd.
Anesthesiology · 362d
Cleared Oct 09, 1996
ANESTHESIA CONDUCTION NEEDLE
K962886
Ispg, Inc.
Anesthesiology · 77d
Cleared Aug 01, 1996
GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725)
K961444
Global Medical Products, Ltd.
Anesthesiology · 108d
Cleared Dec 21, 1995
POLYMEDIC SPINAL NEEDLE AND INTRODUCER
K940061
Techniques Medicales DE Navaree
Anesthesiology · 714d
Cleared Oct 11, 1995
GLOBAL MEDICAL PRODUCTS TUOHY & CRAWFORD EPIDURAL NEEDLE W/PLASTIC HUB
K952275
Global Medical Prods, Inc.
Anesthesiology · 149d
Cleared Aug 11, 1995
EPIDURAL NEEDLE
K942863
Spinal Specialties, Inc.
Anesthesiology · 420d
Cleared Aug 11, 1995
CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA.
K951949
Baxter Healthcare Corp
Anesthesiology · 107d
Cleared Aug 02, 1995
ATRAUMATIC PENCIL POINT SPINAL NEEDLE
K945965
Avid N.I.T., Inc.
Anesthesiology · 238d
Cleared Jul 25, 1995
HOLGRATH METAL-HUB, EPIDURAL NEEDLE
K946047
Holgrath Medical Technologies, Inc.
Anesthesiology · 225d
Cleared Jun 30, 1995
SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE
K950820
Spinal Specialties, Inc.
Anesthesiology · 127d
Cleared Jun 07, 1995
HOLGRATH PLASTIC-HUB, WHITACRE STYLE SPINAL NEEDLE
K944905
Holgrath Medical Technologies, Inc.
Anesthesiology · 245d
Cleared Jun 07, 1995
HOLGRATH PLASTIC-HUB EPIDURAL NEEDLE
K944906
Holgrath Medical Technologies, Inc.
Anesthesiology · 245d
Cleared Jun 07, 1995
HOLGRATH PLASTIC-HUB, QUINCKE SPINAL NEEDLE
K944907
Holgrath Medical Technologies, Inc.
Anesthesiology · 245d
Cleared Jun 07, 1995
HOLGRATH PLASTIC-HUB, COICAL POINT SPINAL NEEDLE
K944908
Holgrath Medical Technologies, Inc.
Anesthesiology · 245d
Cleared May 03, 1995
MONOJECT WHITACRE POINT SPINAL NEEDLE (27G X 3 1/2)
K951312
Sherwood Medical Co.
Anesthesiology · 41d
Cleared May 01, 1995
MONOJECT TUOHY POINT EPIDURAL NEEDLE (22G X 3 1/2)
K951411
Sherwood Medical Co.
Anesthesiology · 34d
Cleared Apr 10, 1995
MONOJECT DIAMOND POINT SPINAL NEEDLE (28G X 3 1/2)
K951265
Sherwood Medical Co.
Anesthesiology · 20d
Cleared Mar 22, 1995
GERTIE MARX NEEDLE
K943649
Manan Medical Products, Inc.
Anesthesiology · 237d
Cleared Feb 01, 1995
ELDOR NEEDLE
K935255
Csen , Ltd.
Anesthesiology · 457d
Cleared Jan 26, 1994
PENCIL POINT SPINAL NEEDLE AND TRAY
K932569
B. Braun of America, Inc.
Anesthesiology · 244d
Cleared Dec 13, 1993
ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY
K932400
B. Braun of America, Inc.
Anesthesiology · 209d
Cleared Sep 22, 1993
GERTIE MARX NEEDLE
K931644
Intl. Medical-Dental Products USA, Inc.
Anesthesiology · 173d
Cleared Aug 26, 1993
PENCIL POINT SPINAL NEEDLE
K921683
Hart Enterprises, Inc.
Anesthesiology · 505d
Cleared Jul 16, 1993
MEDIZIV SPINAL NEEDLE SET
K925831
Medicia Medical Products
Anesthesiology · 242d