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 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
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 Aug 11, 1995
CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA.
K951949
Baxter Healthcare Corp
Anesthesiology · 107d
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 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 Apr 15, 1993
PAJUNK STANDARD SPROTTE NEEDLE W/ INTRODUCER CANN.
K923003
Rusch, Inc.
Anesthesiology · 297d
Cleared Jan 27, 1993
PHARMASEAL CLEAR HUB SPINAL NEEDLE
K920305
Baxter Healthcare Corp
Anesthesiology · 371d
Cleared Jan 27, 1993
CURITY CALIBRATED TUOHY TYPE EPIDURAL NEEDLE
K921288
Kendall Healthcare Products Co. Div.Of Tyco Health
Anesthesiology · 316d
Cleared Jul 24, 1992
ATRAUMATIC SPECIAL SPROTTE NEEDLE
K911221
Pajunk GmbH
Anesthesiology · 493d
Cleared May 04, 1992
ATRAUMATIC STANDARD SPROTTE NEEDLE
K911202
Pajunk GmbH
Anesthesiology · 412d
Cleared Oct 21, 1991
ATRAUMATIC STANDARD SPROTTE NEEDLE
K911260
Pajunk GmbH
Anesthesiology · 213d
Cleared Jul 24, 1991
SPINAL TAP NEEDLE
K910652
Gesco Intl., Inc.
Anesthesiology · 160d
Cleared May 17, 1991
CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING
K910791
Kendall Healthcare Products Co. Div.Of Tyco Health
Anesthesiology · 81d
Cleared Oct 19, 1989
SPINAL NEEDLE
K895453
Advance Medical Designs, Inc.
Anesthesiology · 44d
Cleared Oct 23, 1985
TSK STERIJECT STERILE EPIDURAL NEEDLE
K854149
Pharmacia, Inc.
Anesthesiology · 12d