Tuohy Sono
Tuohy-Kanüle
9manufacturers in China registered for this device type
14catalogue numbers in this listing
13510(k) clearances naming this product code
1recall
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) | K113207 |
| Record published | 2021-07-07 |
| Record revised | 2025-12-01 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment humidity 10 to 65 % RH; Storage environment temperature 10 to 30 °C |
| Sizes | Outer diameter 0.7 to 1.4 mm; length 50 to 150 mm |
| Distribution end date | 2025-07-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1085-4E050 | Outer Diameter 0.7 mm | 25 | Withdrawn |
| 1085-4F120 | Outer Diameter 0.8 mm | 10 | Withdrawn |
| 1085-4K120 | Length 120.0 mm | 10 | Withdrawn |
| 1085-4E070 | Length 70.0 mm | 25 | Withdrawn |
| 1085-4F050 | Outer Diameter 0.8 mm | 25 | Withdrawn |
| 1085-4K050 | Length 50.0 mm | 25 | Withdrawn |
| 1085-4M090 | Length 90.0 mm | 25 | Withdrawn |
| 1085-4K150 | Outer Diameter 1.2 mm | 10 | Withdrawn |
| 1085-4E120 | Length 120.0 mm | 10 | Withdrawn |
| 1085-4K090 | Outer Diameter 1.2 mm | 25 | Withdrawn |
| 1085-4E090 | Length 90.0 mm | 25 | Withdrawn |
| 1085-4G103 | Outer Diameter 0.9 mm | 25 | Withdrawn |
| 1085-4F090 | Outer Diameter 0.8 mm | 25 | Withdrawn |
| 1085-4F070 | Length 70.0 mm | 25 | 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.