Episensor

FDA 510(k) K903224 · Palex Intl. SA

Substantially Equivalent

510(k) numberK903224

Submission

Device name
Episensor
Applicant
Palex Intl. SA
Spain, ES
Received
July 23, 1990
Decision date
December 24, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

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
K905108Contorno(R), Models E and STGEI · Traditional 02/04/1991SE
K904586Palex Irrigation SetEXD · Traditional 12/28/1990SE
K902642Contorno (TM)GEI · Traditional 08/07/1990SE
K901680Bauman Rigid LaryngoscopeCCW · Traditional 07/12/1990SE

Questions and answers

When was Episensor cleared by the FDA?

Episensor (K903224) received a 510(k) decision of Substantially Equivalent on December 24, 1990, 154 days after the submission was received.

What is the product code of K903224?

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