Tuohy NRFit
Tuohy NRFit is a regional-anesthesia needle used to deliver anesthetic or facilitate catheter placement. The stainless-steel cannula connects through a plastic hub with the NRFit connector…
Tuohy NRFit is a regional-anesthesia needle used to deliver anesthetic or facilitate catheter placement. The stainless-steel cannula connects through a plastic hub with the NRFit connector configuration.
Different needle lengths and gauges support the specified epidural or peripheral nerve-block applications. Optional stylets and retaining plates form part of the needle configuration.
Listed Item
Tuohy NRFit 17G x 3 1/2″ ( 90mm ) with spec.Point and plastic hub, 1cm graduated,
Materials and Supply
The cannula and metal stylet portions use 304 stainless steel, with polycarbonate hub or control components. The needles are supplied sterile after ethylene-oxide processing. The range covers gauges from 14 to 22 and specified lengths from 90 to 150 mm.
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) | K160297 |
| Record published | 2016-12-15 |
| Record revised | 2025-03-17 (version 5) |
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 temperature 10 to 30 °C; Storage environment humidity 20 to 65 % RH |
| Packaging | Pack of 25, pack of 10 |
| Sizes | Outer diameter 1.2 to 1.6 mm; length 80 to 150 mm |
| Distribution end date | 2025-03-15 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1166-4O110 | Outer Diameter 1.6 mm | In distribution | |
| 1166-6K091 | Outer Diameter 1.2 mm | In distribution | |
| 1166-4K110 | Outer Diameter 1.2 mm | In distribution | |
| 1166-6O081 | Length 80.0 mm | In distribution | |
| 1166-6K081 | Length 80.0 mm | In distribution | |
| 1166-6M091 | Outer Diameter 1.4 mm | In distribution | |
| 1166-4K150 | Length 150.0 mm | In distribution | |
| 1166-6O081 | 25 | Withdrawn | |
| 1166-4K110 | 10 | Withdrawn | |
| 1166-6K091 | 25 | Withdrawn | |
| 1166-4M090 | 25 | Withdrawn | |
| 1166-4K150 | 10 | Withdrawn | |
| 1166-6G091 | 25 | Withdrawn | |
| 1166-6K081 | 25 | Withdrawn | |
| 1166-4O110 | 25 | Withdrawn | |
| 1166-6M091 | 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.