Remington Medical Inc. Tuohy Epidural Needles
FDA 510(k) K150266 · Remington Medical, Inc.
510(k) numberK150266
Submission
- Device name
- Remington Medical Inc. Tuohy Epidural Needles
- Applicant
- Remington Medical, Inc.
Alpharetta, GA, US - Received
- February 4, 2015
- Decision date
- June 4, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K243690 | SonoMSKBSP · Traditional | PAJUNK GmbH Medizintechnologie | 07/01/2025SE |
| K243682 | SonoPlex STIM; SonoPlex IIBSP · Traditional | PAJUNK GmbH Medizintechnologie | 06/27/2025SE |
| K250774 | SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PunctureBSP · Traditional | PAJUNK GmbH Medizintechnologie | 06/25/2025SE |
| K243525 | SonoTAP and SonoTAP IIBSP · Traditional | PAJUNK GmbH Medizintechnologie | 03/24/2025SE |
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyBSP · Traditional | PAJUNK GmbH Medizintechnologie | 11/22/2024SE |
| K241954 | SonoBlock; SonoBlock IIBSP · Traditional | PAJUNK GmbH Medizintechnologie | 09/11/2024SE |
| K240253 | Reach NeedleBSP · Traditional | Aerin Medical, Inc. | 03/21/2024SE |
| K212982 | Medispine - Spinal Needle, Glospine - Spinal NeedleBSP · Traditional | Global Medikit Limited | 07/29/2022SE |
| K211085 | BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBSP · Traditional | Becton, Dickinson and Company | 07/01/2022SE |
| K210978 | BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer NeedleBSP · Traditional | Becton, Dickinson and Company | 12/22/2021SE |
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| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger…DPW · Special | 08/30/2024SE |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerDPW · Traditional | 01/27/2022SE |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek ChargerDPW · Traditional | 10/07/2021SE |
| K191315 | Remington Medical, Inc. Automatic Cutting Needle (NAC)KNW · Traditional | 07/12/2019SE |
| K130282 | Remington Medical Centrefire 22 Biopsy InstrumentKNW · Traditional | 05/13/2013SE |
| K050884 | Adapter CableDTA · Traditional | 05/19/2005SE |
| K040266 | Core Needle BiopsyKNW · Traditional | 07/09/2004SE |
| K990428 | Drainage BagEXF · Traditional | 08/12/1999SE |
| K983621 | Needle GuideIZH · Traditional | 11/03/1998SE |
Questions and answers
When was Remington Medical Inc. Tuohy Epidural Needles cleared by the FDA?
Remington Medical Inc. Tuohy Epidural Needles (K150266) received a 510(k) decision of Substantially Equivalent on June 4, 2015, 120 days after the submission was received.
What is the product code of K150266?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.