Sprotte® NRFit
SPROTTE NRFit is a spinal anesthesia needle used to deliver anesthetic into the subarachnoid space. It has a straight stainless steel cannula, a stylet and a magnifying hub with an NRFit…
SPROTTE NRFit is a spinal anesthesia needle used to deliver anesthetic into the subarachnoid space. It has a straight stainless steel cannula, a stylet and a magnifying hub with an NRFit connection.
The needle has a symmetrical, noncutting pencil-point tip and a side opening through which fluid passes. The magnifying hub provides a viewing area for cerebrospinal fluid, while the stylet occupies the needle lumen before use.
Listed Item
SPROTTE® NRFit 22G x 4 3/4″ (120mm) with magnification and IntroDucer NRFit 40mm, sterile
Needle Configurations
The NRFit family offers different needle diameters and lengths, with an optional introducer to assist placement. The listed configuration combines a 22G, 120 mm needle with a 40 mm introducer. Needles are intended for single use, and NRFit connections follow the connector standard for neuraxial applications.
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) | K241953 |
| Record published | 2025-06-03 |
| Record revised | 2025-03-17 (version 6) |
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 humidity 20 to 65 % RH; Storage environment temperature 10 to 30 °C |
| Packaging | Pack of 25, pack of 10 |
| Sizes | Length 35 to 150 mm; outer diameter 0.4 to 0.8 mm; needle gauge 20 to 26 G |
| Distribution end date | 2025-03-15 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 021163-26A | Length 103.0 mm | In distribution | |
| 001163-30E | Outer Diameter 0.55 mm | In distribution | |
| 131163-30C | Length 120.0 mm | In distribution | |
| 341163-31A | In distribution | ||
| 041163-30A | Outer Diameter 0.55 mm | In distribution | |
| 321163-31B | In distribution | ||
| 141163-30C | Outer Diameter 0.7 mm | In distribution | |
| 021163-27A | Length 90.0 mm | In distribution | |
| 121163-30A | Outer Diameter 0.55 mm | In distribution | |
| 041163-27A | Outer Diameter 0.4 mm | In distribution | |
| 211163-29A | Outer Diameter 0.5 mm | In distribution | |
| 361163-31B | In distribution | ||
| 321163-31A | Outer Diameter 0.8 mm | In distribution | |
| 001163-29E | Length 35.0 mm | In distribution | |
| 001163-30A | Outer Diameter 0.55 mm | In distribution | |
| 021163-30C | Outer Diameter 0.7 mm | In distribution | |
| 131163-30A | Outer Diameter 0.55 mm | In distribution | |
| 341163-31B | In distribution | ||
| 331163-31A | In distribution | ||
| 331163-31B | Needle Gauge 20.0 G | In distribution | |
| 041163-26A | Needle Gauge 26.0 G | In distribution | |
| 021163-29A | Length 90.0 mm | In distribution | |
| 051163-29A | Outer Diameter 0.5 mm | In distribution | |
| 341163-30C | In distribution | ||
| 221163-30C | Outer Diameter 0.7 mm | In distribution | |
| 031163-27A | Outer Diameter 0.4 mm | In distribution | |
| 061163-29A | Length 150.0 mm | In distribution | |
| 121163-26A | Length 90.0 mm | In distribution | |
| 321163-30C | In distribution | ||
| 021163-30A | Length 103.0 mm | In distribution | |
| 041163-29A | Outer Diameter 0.5 mm | In distribution | |
| 331163-30C | In distribution | ||
| 211163-27A | Outer Diameter 0.4 mm | In distribution | |
| 001163-30C | Length 90.0 mm | In distribution | |
| 071163-30C | Length 50.0 mm | In distribution | |
| 0001163-31 | In distribution | ||
| 231163-27A | 10 | Withdrawn | |
| 0051163-30 | 10 | Withdrawn | |
| 141163-30C | 10 | Withdrawn | |
| 121163-30A | 25 | Withdrawn | |
| 021163-30A | 25 | Withdrawn | |
| 501163-29A | 25 | Withdrawn | |
| 051163-29A | 10 | Withdrawn | |
| 021163-30C | 25 | Withdrawn | |
| 131163-30C | 10 | Withdrawn | |
| 041163-29A | 25 | Withdrawn | |
| 061163-29A | 10 | Withdrawn | |
| 041163-27A | 25 | Withdrawn | |
| 261163-29A | 10 | Withdrawn | |
| 041163-30A | 10 | Withdrawn | |
| 021163-29A | 25 | Withdrawn | |
| 001163-30E | 25 | Withdrawn | |
| 001163-29E | 25 | Withdrawn | |
| 031163-27A | 10 | Withdrawn | |
| 211163-27A | 25 | Withdrawn | |
| 001163-30C | 25 | Withdrawn | |
| 221163-30C | 25 | Withdrawn | |
| 211163-29A | 25 | Withdrawn | |
| 131163-30A | 10 | Withdrawn | |
| 031163-29A | 10 | Withdrawn | |
| 001163-30A | 25 | Withdrawn | |
| 001163-30D | 25 | Withdrawn | |
| 021163-27A | 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 |
| 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.