SonoBlock; SonoBlock II

510(k) Number

K241954 ↗

FDA product code

BSP

Models / Variants

SonoBlock

SonoBlock II

Device class

Class II

Regulation

21 CFR Part 868.5150

Advisory committee

Anesthesiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)).

• SPINAL EPIDURAL NEEDLES by Te ME NA S.A.R.L.
• GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725) by Global Medical Products, Ltd.
• EchoGlo Needle by Smiths Medical Asd, Inc.
• EPIDURAL NEEDLE by MANAN MEDICAL PRODUCTS, INC.
• MEDIZIV SPINAL NEEDLE SET by Medicia Medical Products
• MODIFICATION TO PLEXOLONG SETS by Pajunk GmbH
• Medispine Spinal Needle, Glospine Spinal Needle by Global Medikit Limited
• PERIFIX SAFETY EPIDURAL NEEDLES by B. Braun Medical, Inc.
• LAURIMED SPINAL INJECTION SYSTEM by Laurimed, LLC
• BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle by Becton, Dickinson and Company

• Tuohy II 1170-6I091

  Class II

  FDA 510(k) K160297 Active Cleared 28 Oct 2016 GUDID on market

• Tuohy II 1170-6K081

  Class II

  FDA 510(k) K160297 Active Cleared 28 Oct 2016 GUDID on market

• Tuohy II 1170-6K120

  Class II

  FDA 510(k) K160297 Active Cleared 28 Oct 2016 GUDID on market

• Tuohy II 1170-6K091

  Class II

  FDA 510(k) K160297 Active Cleared 28 Oct 2016 GUDID on market

See all devices from Pajunk GmbH Medizintechnologie →