SonoPlex Stim
SonoPlex Stim is a single-use nerve-block needle for injecting local anesthetics to produce regional anesthesia. It supports ultrasound guidance, with CornerStone reflectors enhancing…
SonoPlex Stim is a single-use nerve-block needle for injecting local anesthetics to produce regional anesthesia. It supports ultrasound guidance, with CornerStone reflectors enhancing visibility, and an electrical stimulus can assist localization through the connecting cable.
The needle is supplied with an injection tube and cable and has a NanoLine parylene coating. Tubing connections use a Luer or NRFit connector depending on configuration.
Listed Item
SonoPlex STIM 20G (0,90) x 150mm, with injection tube and connecting cable
Procedure Limits
The cannula is not intended for intrathecal use. Typical use lasts less than 60 minutes, with a specified maximum intended duration of 24 hours. The reflectors and stimulation connection provide complementary guidance methods.
Who Else Makes It
Concentrated in Zhejiang (5), Shanghai (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
| Ningbo Linstant Polymer Materials Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 1 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Zhejiang Medicines & Health Products I/ E Co., Ltd. | Hangzhou | Zhejiang | Exporter | 41 |
| Zhejiang Kindly Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Shanghai Mekon Medical Devices Co., Ltd. | Shanghai | Shanghai | Exporter | 11 |
| Tianjin Hanaco Medical Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 3 |
| Shanghai SA Medical & Plastic Instruments Co., Ltd. | Shanghai | Shanghai | Manufacturer | 1 |
Record
| Listed by | Pajunk Gmbh Medizintechnologie, Germany |
|---|---|
| FDA product code | BSP |
| Device type | Needle, Conduction, Anesthetic (W/Wo Introducer) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5150 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer |
| 510(k) | K243682 |
| Record published | 2016-08-30 |
| Record revised | 2025-03-17 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment humidity 20 to 65 % RH; Storage environment temperature 10 to 30 °C |
| Packaging | Pack of 10 |
| Sizes | Length 40 to 150 mm; outer diameter 0.7 to 0.9 mm; needle gauge 21 to 22 G |
| Distribution end date | 2025-07-16 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 001187-77 | Outer Diameter 0.8 mm | In distribution | |
| 001187-72 | Length 120.0 mm | In distribution | |
| 001185-71 | Length 80.0 mm | In distribution | |
| 001185-31H | Length 70.0 mm | In distribution | |
| 001187-71 | Outer Diameter 0.7 mm | In distribution | |
| 001185-77 | Outer Diameter 0.8 mm | In distribution | |
| 001185-70 | Outer Diameter 0.7 mm | In distribution | |
| 001185-76 | Outer Diameter 0.9 mm | In distribution | |
| 001185-74 | Length 50.0 mm | In distribution | |
| 001185-72 | Length 120.0 mm | In distribution | |
| 001185-31G | Length 50.0 mm | In distribution | |
| 001187-74 | Outer Diameter 0.7 mm | In distribution | |
| 001187-76 | Outer Diameter 0.9 mm | In distribution | |
| 001185-31G | 10 | Withdrawn | |
| 001187-78 | 10 | Withdrawn | |
| 001185-76 | 10 | Withdrawn | |
| 001187-72 | 10 | Withdrawn | |
| 001185-31H | 10 | Withdrawn | |
| 001187-88 | Length 80.0 mm | Withdrawn | |
| 001187-85 | 10 | Withdrawn | |
| 001185-72 | 10 | Withdrawn | |
| 001187-74 | 10 | Withdrawn | |
| 001185-88 | Length 80.0 mm | Withdrawn | |
| 001187-93 | Needle Gauge 22.0 G | Withdrawn | |
| 001185-71 | 10 | Withdrawn | |
| 001187-76 | 10 | Withdrawn | |
| 001185-75 | 10 | Withdrawn | |
| 001185-74 | 10 | Withdrawn | |
| 001185-30G | 10 | Withdrawn | |
| 001185-31J | 10 | Withdrawn | |
| 001187-70 | 10 | Withdrawn | |
| 001185-85 | 10 | Withdrawn | |
| 001185-70 | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Halyard | Avanos Medical, Inc. | 386 |
| Sprotte® | Pajunk Gmbh Medizintechnologie | 273 |
| Avanos | Avanos Medical, Inc. | 264 |
| Epimed | Epimed International, Inc. | 131 |
| Phoenix | DR. Japan Co., Ltd. | 128 |
| Tuohy | Pajunk Gmbh Medizintechnologie | 128 |
| Lccs | Lccs Products Limited | 121 |
| Arrow | Teleflex Medical LLC | 104 |
| Reli | Myco Medical Supplies, Inc. | 86 |
| Sonoblock | Pajunk Gmbh Medizintechnologie | 70 |
| Temena | Temena GmbH | 67 |
| Sprotte® NRFit | Pajunk Gmbh Medizintechnologie | 63 |
Showing 12 of 149. All products under Needle, Conduction, Anesthetic (W/Wo Introducer)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243690 | 2025-07-01 |
| K243682 | 2025-06-27 |
| K250774 | 2025-06-25 |
| K243525 | 2025-03-24 |
| K241953 | 2024-11-22 |
| K241954 | 2024-09-11 |
| K170435 | 2017-07-12 |
| K160297 | 2016-10-28 |
| K160296 | 2016-10-27 |
| K160295 | 2016-10-27 |
| K160294 | 2016-10-21 |
| K111374 | 2011-08-29 |
| K063350 | 2008-02-01 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2019-08-30 | Class II | Process control | Problem with packaging sealing process which affects sterility. | 40,475 devices |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.