Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
The Fascile Continuous Peripheral Nerve Block Kit places an open-tip catheter near a peripheral nerve bundle for regional anesthesia and pain management. The catheter fits over the needle,…
The Fascile Continuous Peripheral Nerve Block Kit places an open-tip catheter near a peripheral nerve bundle for regional anesthesia and pain management. The catheter fits over the needle, which guides placement and is then withdrawn to leave the catheter available for infusion.
The catheter connects to a syringe or infusion pump for continuous or intermittent delivery of local anesthetic or analgesic. Ultrasound visualization can guide placement in the listed non-stimulation kit configuration.
Listed Item
Needle 20 gauge, Catheter 4 French X 100 mm Mini Kit (50cm Extension, non-stimulation)
Infusion Period
The catheter may remain in place for up to 72 hours during care before, during or after surgery. Other kit configurations can include a stimulation cable for nerve localization; that accessory depends on the selected set.
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 | Solo-DEX, United States |
|---|---|
| FDA product code | BSP |
| Device type | Needle, Conduction, Anesthetic (W/Wo Introducer) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5150 |
| Establishment | Manufacturer |
| 510(k) | K151072 |
| Record published | 2023-05-09 |
| Record revised | 2023-05-08 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10 of 10, box of 100 of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 500027 | In distribution | |
| 500014 | In distribution | |
| 500030 | In distribution | |
| 500035 | In distribution | |
| 500008 | In distribution | |
| 500020 | In distribution |
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 |
|---|---|
| K151072 | 2016-01-22 |
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.