BSP · Needle, Conduction, Anesthetic (W/Wo Introducer)
Anesthesiology · 21 CFR 868.5150 · Class 2
Overview
| Product Code | BSP |
|---|---|
| Device Name | Needle, Conduction, Anesthetic (W/Wo Introducer) |
| Regulation | 21 CFR 868.5150 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 152)
Showing 20 most recent of 152 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243690 | SonoMSK | PAJUNK GmbH Medizintechnologie | Jul 1, 2025 | SESE |
| K243682 | SonoPlex STIM; SonoPlex II | PAJUNK GmbH Medizintechnologie | Jun 27, 2025 | SESE |
| K250774 | SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture | PAJUNK GmbH Medizintechnologie | Jun 25, 2025 | SESE |
| K243525 | SonoTAP and SonoTAP II | PAJUNK GmbH Medizintechnologie | Mar 24, 2025 | SESE |
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology | PAJUNK GmbH Medizintechnologie | Nov 22, 2024 | SESE |
| K241954 | SonoBlock; SonoBlock II | PAJUNK GmbH Medizintechnologie | Sep 11, 2024 | SESE |
| K240253 | Reach Needle | Aerin Medical, Inc. | Mar 21, 2024 | SESE |
| K212982 | Medispine - Spinal Needle, Glospine - Spinal Needle | Global Medikit Limited | Jul 29, 2022 | SESE |
| K211085 | BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle | Becton, Dickinson and Company | Jul 1, 2022 | SESE |
| K210978 | BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle | Becton, Dickinson and Company | Dec 22, 2021 | SESE |
| K203668 | RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles | Myco Medical Supplies, Inc. | Sep 29, 2021 | SESE |
| K212328 | DiscCath Needle Set | Disccath, LLC | Sep 26, 2021 | SESE |
| K193131 | BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle | Becton, Dickinson and Company | Sep 29, 2020 | SESE |
| K192914 | Stimuplex Onvision System | Philips Medical Systems Nederland B.V. | May 27, 2020 | SESE |
| K191290 | Ancora Nerve Block Catheter Set | Ancora Medical Technology | Feb 6, 2020 | SESE |
| K190026 | Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) | Teleflex Medical | Aug 21, 2019 | SESE |
| K183316 | Dr J Spinal and Epidural Needles | Dr. Japan Co., Ltd. | Aug 12, 2019 | SESE |
| K172823 | Portex NRFit Epidural Needles | Smiths Medical Asd, Inc. | Jun 12, 2018 | SESE |
| K173155 | Pakter Curved Needle Set | Cook Incorporated | Jun 7, 2018 | SESE |
| K172410 | Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters | Smiths Medical Asd, Inc. | Jun 1, 2018 | SESE |
Top Applicants
- PAJUNK GmbH Medizintechnologie — 13 clearances
- Pajunk GmbH — 8 clearances
- B.Braun Medical, Inc. — 5 clearances
- Epimed International, Inc. — 5 clearances
- Holgrath Medical Technologies, Inc. — 5 clearances
