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 R. J. Doyle, Inc..

152
Total
152
Cleared
185d
Avg days
1981
Since
152 devices
121–144 of 152
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 30, 1991
MICRO-SP LUMBAR PUNCTURE (SPINAL) NEEDLE
K901810
Neuro Technology
Anesthesiology · 405d
Cleared May 28, 1991
ADD'L DATA E-SP MULTIPURPOSE EPIDURAL SPINALNEEDLE
K901811
Neuro Technology
Anesthesiology · 403d
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 Dec 24, 1990
EPISENSOR
K903224
Palex Intl. SA
Anesthesiology · 154d
Cleared Nov 30, 1989
16GA X 6 BULLET POINT NEEDLE, FLEX STAINLESS STEE
K894878
R. J. Doyle, Inc.
Anesthesiology · 121d
Cleared Nov 30, 1989
16GA X 10 MIDDLE SIZE BULLET POINT NEEDLE
K894879
R. J. Doyle, Inc.
Anesthesiology · 121d
Cleared Nov 30, 1989
16GA X 14 FOURTEEN LONG LONG BULLET POINT NEEDL
K894880
R. J. Doyle, Inc.
Anesthesiology · 121d
Cleared Nov 30, 1989
20GA X 7-1/2 THREADING BULLET POINT NEEDLE
K894881
R. J. Doyle, Inc.
Anesthesiology · 121d
Cleared Nov 30, 1989
INFILTRATION PUMP SYRINGE
K894882
R. J. Doyle, Inc.
Anesthesiology · 121d
Cleared Oct 19, 1989
SPINAL NEEDLE
K895453
Advance Medical Designs, Inc.
Anesthesiology · 44d
Cleared Jan 15, 1986
PINPOINT NEEDLE
K853478
Regional Master Corp.
Anesthesiology · 154d
Cleared Dec 19, 1985
EPIDURAL ANESTHESIA NEEDLES
K854816
Reganes, Inc.
Anesthesiology · 16d
Cleared Oct 23, 1985
TSK STERIJECT STERILE EPIDURAL NEEDLE
K854149
Pharmacia, Inc.
Anesthesiology · 12d
Cleared May 07, 1985
VYGON SPINAL ANESTHESIA NEEDLE W/INTRODUCER 183
K851478
Vygon Corp.
Anesthesiology · 22d
Cleared Jan 24, 1985
AIRES TUOHY NEEDLES 17GA. X 4 1/2
K850111
Aries Medical, Inc.
Anesthesiology · 10d
Cleared Sep 19, 1984
TOP DISPOSABLE SPINAL NEEDLE
K843313
Top Surgical Manufacturers Co.
Anesthesiology · 26d
Cleared Aug 12, 1983
MICRO Z DISPOS. SPINAL ANESTH. NEEDLE
K832126
Smith & Nephew, Mpl Division
Anesthesiology · 42d