Tuohy
Tuohy with spec.Point,1cm grad. 18G x 3 1/2" (90mm), plastic stylet
9manufacturers in China registered for this device type
128catalogue 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) | K040965 |
| Record published | 2021-07-07 |
| Record revised | 2025-12-01 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| 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 25, pack of 10 |
| Sizes | Length 50 to 200 mm; outer diameter 0.7 to 1.6 mm; needle gauge 18 to 22 G; total volume 0.23 to 0.28 ml |
| Distribution end date | 2026-07-17 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1150-4K120 | Outer Diameter 1.2 mm | In distribution | |
| 1150-4K090 | Needle Gauge 18.0 G | In distribution | |
| 1150-4G090 | Length 90.0 mm | In distribution | |
| 1150-6K091 | Length 90.0 mm | In distribution | |
| 1150-7M091G | Outer Diameter 0.9 mm | In distribution | |
| 1150-4K150 | Outer Diameter 1.2 mm | In distribution | |
| 1150-7M091G | Outer Diameter 0.9 mm | In distribution | |
| 1150-4F090 | Length 90.0 mm | In distribution | |
| 1150-4M120 | Length 120.0 mm | In distribution | |
| 1150-4M150 | Length 150.0 mm | In distribution | |
| 1150-4K080 | Outer Diameter 1.2 mm | In distribution | |
| 1150-4M090 | Outer Diameter 1.4 mm | In distribution | |
| 1150-2G090G | Outer Diameter 0.9 mm | In distribution | |
| 1150-6M091 | Outer Diameter 1.4 mm | In distribution | |
| 1150-2G090G | Outer Diameter 0.9 mm | In distribution | |
| 1150-6G091 | Outer Diameter 0.9 mm | 10 | Withdrawn |
| 1150-2G090 | Length 90.0 mm | 10 | Withdrawn |
| 1150-4K120 | Outer Diameter 1.2 mm | 10 | Withdrawn |
| 1150-6G091 | 10 | Withdrawn | |
| 1150-4K080 | 25 | Withdrawn | |
| 1150-4M120 | Outer Diameter 1.4 mm | 25 | Withdrawn |
| 1150-4K050 | 25 | Withdrawn | |
| 1150-4K200 | 10 | Withdrawn | |
| 1085-4F070 | Length 70.0 mm | 25 | Withdrawn |
| 1150-4K150 | Outer Diameter 1.2 mm | 10 | Withdrawn |
| 1150-4E080 | 25 | Withdrawn | |
| 1085-4M090 | Length 90.0 mm | 25 | Withdrawn |
| 1085-4F090 | Outer Diameter 0.8 mm | 25 | Withdrawn |
| 1150-4M090 | Outer Diameter 1.4 mm | 25 | Withdrawn |
| 1150-8G103 | Outer Diameter 0.9 mm | 10 | Withdrawn |
| 1150-4M150 | 10 | Withdrawn | |
| 1150-4G103 | Length 103.0 mm | 25 | Withdrawn |
| 1166-6O081 | Outer Diameter 1.6 mm | 25 | Withdrawn |
| 1150-4K050 | Outer Diameter 1.2 mm | 25 | Withdrawn |
| 1085-4E120 | Length 120.0 mm | 10 | Withdrawn |
| 1150-4M090 | Length 90.0 mm | 25 | Withdrawn |
| 1166-6G091 | Length 90.0 mm | 25 | Withdrawn |
| 1150-4M090 | 25 | Withdrawn | |
| 1085-4F050 | Length 50.0 mm | 25 | Withdrawn |
| 1085-4K150 | Outer Diameter 1.2 mm | 10 | Withdrawn |
| 1150-7G103 | Outer Diameter 0.9 mm | 10 | Withdrawn |
| 1150-4O150 | Length 150.0 mm | 10 | Withdrawn |
| 1150-4G090 | Outer Diameter 0.9 mm | 25 | Withdrawn |
| 1150-4O090 | 25 | Withdrawn | |
| 1166-4M090 | Length 90.0 mm | 25 | Withdrawn |
| 1166-6K091 | Outer Diameter 1.2 mm | 25 | Withdrawn |
| 1150-4G120 | Length 120.0 mm | 10 | Withdrawn |
| 1150-4O090 | Length 90.0 mm | 25 | Withdrawn |
| 1150-4M150 | Length 150.0 mm | 10 | Withdrawn |
| 1166-6M091 | Outer Diameter 1.4 mm | 25 | Withdrawn |
| 1150-6K091 | Outer Diameter 1.3 mm | 25 | Withdrawn |
| 1150-8G103 | Length 103.0 mm | 10 | Withdrawn |
| 1150-6K091 | 25 | Withdrawn | |
| 1166-6G091 | Length 90.0 mm | 25 | Withdrawn |
| 1166-4K150 | Length 150.0 mm | 10 | Withdrawn |
| 1150-4G150 | Outer Diameter 0.9 mm | 10 | Withdrawn |
| 1150-4E090 | Outer Diameter 0.7 mm | 25 | Withdrawn |
| 1150-4F090 | Outer Diameter 0.8 mm | 25 | Withdrawn |
| 1150-7G103 | Outer Diameter 0.9 mm | 10 | Withdrawn |
| 1150-4M120 | 25 | Withdrawn | |
| 1150-4K080 | Length 80.0 mm | 25 | Withdrawn |
| 1150-8G103 | 10 | Withdrawn | |
| 1166-6K081 | Length 80.0 mm | 25 | Withdrawn |
| 1166-4O110 | Length 110.0 mm | 25 | Withdrawn |
| 1150-4G150 | Length 150.0 mm | 10 | Withdrawn |
| 1150-4M100 | Length 100.0 mm | 25 | Withdrawn |
| 1150-4M150 | Length 150.0 mm | 10 | Withdrawn |
| 1166-4M090 | Length 90.0 mm | 25 | Withdrawn |
| 1150-6G091 | Outer Diameter 0.9 mm | 10 | Withdrawn |
| 1085-4F120 | Outer Diameter 0.8 mm | 10 | Withdrawn |
| 1150-4T100 | 25 | Withdrawn | |
| 1150-4E090 | Length 90.0 mm | 25 | Withdrawn |
| 1150-4O150 | 10 | Withdrawn | |
| 1150-4E120 | Outer Diameter 0.7 mm | 10 | Withdrawn |
| 1150-4K200 | Outer Diameter 1.2 mm | 10 | Withdrawn |
| 1150-4K080 | Outer Diameter 1.2 mm | 25 | Withdrawn |
| 1150-4K150 | 10 | Withdrawn | |
| 1150-4M200 | Outer Diameter 1.4 mm | 10 | Withdrawn |
| 1150-4K200 | Length 200.0 mm | 10 | Withdrawn |
| 1150-4E120 | 10 | Withdrawn | |
| 1150-4E100 | Needle Gauge 22 G | Withdrawn | |
| 1150-4M200 | 10 | Withdrawn | |
| 1085-4K050 | Length 50.0 mm | 25 | Withdrawn |
| 1166-4O110 | Total Volume 0.28 ml | 25 | Withdrawn |
| 1166-4K150 | Length 150.0 mm | 10 | Withdrawn |
| 1085-4E050 | Length 50.0 mm | 25 | Withdrawn |
| 1150-4G090 | 25 | Withdrawn | |
| 1166-4K110 | Length 110.0 mm | 10 | Withdrawn |
| 1150-4M080 | 25 | Withdrawn | |
| 1150-4K090 | 25 | Withdrawn | |
| 1150-4I090 | Outer Diameter 1.1 mm | 25 | Withdrawn |
| 1150-6M091 | 25 | Withdrawn | |
| 1150-4G150 | 10 | Withdrawn | |
| 1085-4E090 | Outer Diameter 0.7 mm | 25 | Withdrawn |
| 1150-4M080 | Length 80.0 mm | 25 | Withdrawn |
| 1150-4F090 | Length 90.0 mm | 25 | Withdrawn |
| 1150-4I090 | 25 | Withdrawn | |
| 1150-4M200 | Length 200.0 mm | 10 | Withdrawn |
| 1166-6M091 | Outer Diameter 1.4 mm | 25 | Withdrawn |
| 1150-4E080 | Length 80.0 mm | 25 | Withdrawn |
| 1150-4G120 | 10 | Withdrawn | |
| 1150-4G103 | Outer Diameter 0.9 mm | 25 | Withdrawn |
| 1150-2G090 | Outer Diameter 0.9 mm | 10 | Withdrawn |
| 1150-4E080 | Outer Diameter 0.7 mm | 25 | Withdrawn |
| 1150-4I090 | Outer Diameter 1.1 mm | 25 | Withdrawn |
| 1150-4K120 | 10 | Withdrawn | |
| 1150-4O150 | Outer Diameter 1.6 mm | 10 | Withdrawn |
| 1150-4M120 | Outer Diameter 1.4 mm | 25 | Withdrawn |
| 1150-4G103 | 25 | Withdrawn | |
| 1150-4E090 | 25 | Withdrawn | |
| 1150-4G090 | Outer Diameter 0.9 mm | 25 | Withdrawn |
| 1166-6O081 | Outer Diameter 1.6 mm | 25 | Withdrawn |
| 1166-6K081 | Outer Diameter 1.2 mm | 25 | Withdrawn |
| 1150-6M091 | Length 90.0 mm | 25 | Withdrawn |
| 1166-4K110 | Outer Diameter 1.2 mm | 10 | Withdrawn |
| 1166-6K091 | Length 90.0 mm | 25 | Withdrawn |
| 1085-4K120 | Outer Diameter 1.2 mm | 10 | Withdrawn |
| 1150-4F090 | 25 | Withdrawn | |
| 1085-4K090 | Outer Diameter 1.2 mm | 25 | Withdrawn |
| 1150-4M100 | Outer Diameter 1.4 mm | 25 | Withdrawn |
| 1150-4K150 | Length 152.0 mm | 10 | Withdrawn |
| 1085-4E070 | Outer Diameter 0.7 mm | 25 | Withdrawn |
| 1150-4G120 | Outer Diameter 0.9 mm | 10 | Withdrawn |
| 1150-4K120 | Length 120.0 mm | 10 | Withdrawn |
| 1150-4M100 | 25 | Withdrawn | |
| 1150-4M080 | Length 80.0 mm | 25 | Withdrawn |
| 1150-4K050 | Outer Diameter 1.2 mm | 25 | Withdrawn |
| 1150-4E120 | Outer Diameter 0.7 mm | 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 |
| 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 |
| 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.