Sonoblock
The FDA filing identifies SonoBlock and SonoBlock II as single-use anesthesia conduction nerve-block needles for peripheral nerve blocks under ultrasound guidance. The needles puncture…
The FDA filing identifies SonoBlock and SonoBlock II as single-use anesthesia conduction nerve-block needles for peripheral nerve blocks under ultrasound guidance.
The needles puncture tissue to gain entry and inject local anesthetic for regional anesthesia. The filing says they are not intended for radiofrequency ablation or other ablation procedures.
Listed Item
SonoBlock 20G (0,90) x 120mm with injection tube
Device-Family Note
The filing also distinguishes SonoBlock II as a directly injection-moulded option in comparison with the glued predicate design.
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) | K241954 |
| Record published | 2021-04-02 |
| Record revised | 2025-12-01 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 temperature 10 to 30 °C; Storage environment humidity 10 to 65 % RH |
| Packaging | Pack of 10 |
| Sizes | Length 40 to 150 mm; outer diameter 0.7 to 0.9 mm; needle gauge 21 to 25 G |
| Distribution end date | 2026-07-17 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 001180-31G | In distribution | ||
| 001180-71 | In distribution | ||
| 001180-81 | Needle Gauge 25.0 G | In distribution | |
| 001180-77 | In distribution | ||
| 001181-71 | In distribution | ||
| 001180-74 | In distribution | ||
| 001181-74 | In distribution | ||
| 001181-77 | In distribution | ||
| 001280-72 | 10 | Withdrawn | |
| 001180-31G | 10 | Withdrawn | |
| 001265-70 | Length 40.0 mm | 10 | Withdrawn |
| 001180-71 | 10 | Withdrawn | |
| 001180-31G | 10 | Withdrawn | |
| 001267-70 | Outer Diameter 0.7 mm | 10 | Withdrawn |
| 001180-30G | 10 | Withdrawn | |
| 001267-72 | Length 120.0 mm | 10 | Withdrawn |
| 001265-74 | Outer Diameter 0.7 mm | 10 | Withdrawn |
| 001260-71 | 10 | Withdrawn | |
| 001181-93 | Needle Gauge 22.0 G | Withdrawn | |
| 001260-77 | 10 | Withdrawn | |
| 001181-74 | 10 | Withdrawn | |
| 001180-85 | Length 50.0 mm | Withdrawn | |
| 001180-30G | 10 | Withdrawn | |
| 001180-71 | 10 | Withdrawn | |
| 001180-77 | 10 | Withdrawn | |
| 001181-78 | Needle Gauge 24.0 G | Withdrawn | |
| 001180-70 | 10 | Withdrawn | |
| 001180-31J | 10 | Withdrawn | |
| 001265-76 | 10 | Withdrawn | |
| 001267-74 | Outer Diameter 0.7 mm | 10 | Withdrawn |
| 001180-72 | 10 | Withdrawn | |
| 001180-31H | 10 | Withdrawn | |
| 001180-31H | 10 | Withdrawn | |
| 001280-71 | 10 | Withdrawn | |
| 001181-88 | Length 80.0 mm | Withdrawn | |
| 001280-95 | 10 | Withdrawn | |
| 001281-74 | 10 | Withdrawn | |
| 001180-74 | 10 | Withdrawn | |
| 001181-74 | 10 | Withdrawn | |
| 001181-77 | 10 | Withdrawn | |
| 001281-70 | 10 | Withdrawn | |
| 001267-77 | Length 100.0 mm | 10 | Withdrawn |
| 001260-74 | 10 | Withdrawn | |
| 001280-74 | 10 | Withdrawn | |
| 001281-77 | 10 | Withdrawn | |
| 001265-71 | Outer Diameter 0.7 mm | 10 | Withdrawn |
| 001181-70 | 10 | Withdrawn | |
| 001281-71 | 10 | Withdrawn | |
| 001181-72 | 10 | Withdrawn | |
| 001267-76 | Outer Diameter 0.9 mm | 10 | Withdrawn |
| 001265-72 | Length 120.0 mm | 10 | Withdrawn |
| 001281-95 | 10 | Withdrawn | |
| 001265-77 | Outer Diameter 0.8 mm | 10 | Withdrawn |
| 001180-78 | Length 40.0 mm | Withdrawn | |
| 001260-89 | 10 | Withdrawn | |
| 001281-72 | 10 | Withdrawn | |
| 001180-70 | 10 | Withdrawn | |
| 001280-77 | 10 | Withdrawn | |
| 001181-70 | 10 | Withdrawn | |
| 001181-71 | 10 | Withdrawn | |
| 001181-71 | 10 | Withdrawn | |
| 001181-81 | Needle Gauge 25.0 G | Withdrawn | |
| 001181-94 | Length 70.0 mm | Withdrawn | |
| 001267-71 | Length 80.0 mm | 10 | Withdrawn |
| 001181-72 | 10 | Withdrawn | |
| 001180-72 | 10 | Withdrawn | |
| 001180-74 | 10 | Withdrawn | |
| 001181-77 | 10 | Withdrawn | |
| 001180-31J | 10 | Withdrawn | |
| 001180-77 | 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 |
| Temena | Temena GmbH | 67 |
| Sprotte® NRFit | Pajunk Gmbh Medizintechnologie | 63 |
| Spinal Needle | Hakko Co., Ltd. | 51 |
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.