Sono-Series Cornerstone Technique

FDA 510(k) K111374 · PAJUNK GmbH Medizintechnologie

Substantially Equivalent

510(k) numberK111374

Submission

Device name
Sono-Series Cornerstone Technique
Applicant
PAJUNK GmbH Medizintechnologie
Geisingen, DE
Received
May 16, 2011
Decision date
August 29, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BSP – Needle, Conduction, Anesthetic (W/Wo Introducer)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5150
Specialty
Anesthesiology

Other 510(k)s with product code BSP

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K243690SonoMSKBSP · Traditional PAJUNK GmbH Medizintechnologie07/01/2025SE
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K250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PunctureBSP · Traditional PAJUNK GmbH Medizintechnologie06/25/2025SE
K243525SonoTAP and SonoTAP IIBSP · Traditional PAJUNK GmbH Medizintechnologie03/24/2025SE
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K241954SonoBlock; SonoBlock IIBSP · Traditional PAJUNK GmbH Medizintechnologie09/11/2024SE
K240253Reach NeedleBSP · Traditional Aerin Medical, Inc.03/21/2024SE
K212982Medispine - Spinal Needle, Glospine - Spinal NeedleBSP · Traditional Global Medikit Limited07/29/2022SE
K211085BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBSP · Traditional Becton, Dickinson and Company07/01/2022SE
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More from Becton, Dickinson and Company

510(k)DeviceDecision
K243690SonoMSKBSP · Traditional 07/01/2025SE
K243682SonoPlex STIM; SonoPlex IIBSP · Traditional 06/27/2025SE
K250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PunctureBSP · Traditional 06/25/2025SE
K243525SonoTAP and SonoTAP IIBSP · Traditional 03/24/2025SE
K241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyBSP · Traditional 11/22/2024SE
K241954SonoBlock; SonoBlock IIBSP · Traditional 09/11/2024SE
K230701Stim2GoIPF · Traditional 11/24/2023SE
K230201Disposable Pre-calibrated Brain Biopsy Needle 2.0HAW · Special 02/22/2023SE
K220897Disposable Brain Biopsy Needle 2.0HAW · Traditional 08/17/2022SE
K202699E-Cath STIM acc. TsuiCAZ · Special 12/29/2020SE

Questions and answers

When was Sono-Series Cornerstone Technique cleared by the FDA?

Sono-Series Cornerstone Technique (K111374) received a 510(k) decision of Substantially Equivalent on August 29, 2011, 105 days after the submission was received.

What is the product code of K111374?

The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.