Spinal Needles

FDA 510(k) K961151 · Hakko Shoji Co., Ltd.

Substantially Equivalent

510(k) numberK961151

Submission

Device name
Spinal Needles
Applicant
Hakko Shoji Co., Ltd.
Cincinnati, OH, US
Received
March 22, 1996
Decision date
March 19, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

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510(k)DeviceApplicantDecision
K243690SonoMSKBSP · Traditional PAJUNK GmbH Medizintechnologie07/01/2025SE
K243682SonoPlex STIM; SonoPlex IIBSP · Traditional PAJUNK GmbH Medizintechnologie06/27/2025SE
K250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PunctureBSP · Traditional PAJUNK GmbH Medizintechnologie06/25/2025SE
K243525SonoTAP and SonoTAP IIBSP · Traditional PAJUNK GmbH Medizintechnologie03/24/2025SE
K241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyBSP · Traditional PAJUNK GmbH Medizintechnologie11/22/2024SE
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
K210978BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer NeedleBSP · Traditional Becton, Dickinson and Company12/22/2021SE

More from Becton, Dickinson and Company

510(k)DeviceDecision
K020307Lap Disc 120 X 120MM X 2CM #LD111; Lap Disc 120 X 120MM X 7CM #LD112GCJ · Traditional 04/26/2002SE
K961152Tuohy Epidural NeedlesBSP · Traditional 03/19/1997SE

Questions and answers

When was Spinal Needles cleared by the FDA?

Spinal Needles (K961151) received a 510(k) decision of Substantially Equivalent on March 19, 1997, 362 days after the submission was received.

What is the product code of K961151?

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