Sprotte®
The FDA filing identifies the SPROTTE STANDARD Luer/NRFit anesthesia conduction needle and states that it is used to administer anesthetic agent to the subarachnoid space. The…
The FDA filing identifies the SPROTTE STANDARD Luer/NRFit anesthesia conduction needle and states that it is used to administer anesthetic agent to the subarachnoid space.
The subject-device description calls it single-use, with a straight cannula and stylet; Luer and NRFit hub options are listed. The filing describes a Sprotte pencil-point tip with a side-hole opening.
Listed Item
SPROTTE® 27G x 4 3/4″ (120mm) with magnification and Introducer, sterile
Listed Size Range
The filing says technical specifications vary by diameter, length and whether an introducer is included. It lists diameters from 22G to 29G and lengths from 35 mm to 150 mm.
9manufacturers in China registered for this device type
273catalogue 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) | K241953 |
| Record published | 2025-06-17 |
| Record revised | 2025-05-29 (version 11) |
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 humidity 20 to 65 % RH; Storage environment temperature 10 to 30 °C |
| Packaging | Pack of 25, pack of 10 |
| Sizes | Length 25 to 200 mm; outer diameter 0.36 to 1.1 mm; needle gauge 25 to 27 G; total volume 0.13 ml |
| Distribution end date | 2025-11-05 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 001151-30A | Outer Diameter 0.55 mm | In distribution | |
| 001151-30C | Outer Diameter 0.7 mm | In distribution | |
| 141151-30C | Outer Diameter 0.7 mm | In distribution | |
| 111151-27A | Length 35.0 mm | In distribution | |
| 221151-30C | Length 103.0 mm | In distribution | |
| 061151-29A | Length 150.0 mm | In distribution | |
| 041151-30A | Outer Diameter 0.55 mm | In distribution | |
| 331151-31A | Length 120.0 mm | 25 | In distribution |
| 511151-29A | Outer Diameter 0.5 mm | In distribution | |
| 121151-30A | Outer Diameter 0.55 mm | In distribution | |
| 121163-30A | Length 90.0 mm | 25 | In distribution |
| 041151-29A | Length 103.0 mm | In distribution | |
| 141151-27A | Length 103.0 mm | In distribution | |
| 321151-30F | In distribution | ||
| 001151-30E | Outer Diameter 0.55 mm | In distribution | |
| 071151-30C | Outer Diameter 0.7 mm | In distribution | |
| 031151-30C | Outer Diameter 0.7 mm | In distribution | |
| 031151-30A | Length 120.0 mm | In distribution | |
| 041151-26A | Needle Gauge 26.0 G | In distribution | |
| 151151-27A | Length 120.0 mm | In distribution | |
| 231151-27A | Outer Diameter 0.4 mm | In distribution | |
| 121151-27A | Outer Diameter 0.4 mm | In distribution | |
| 001151-29E | Outer Diameter 0.5 mm | In distribution | |
| 031151-29A | Outer Diameter 0.5 mm | In distribution | |
| 021163-29A | Length 90.0 mm | 25 | In distribution |
| 121151-26A | Length 90.0 mm | In distribution | |
| 021151-26A | Length 103.0 mm | In distribution | |
| 131151-30A | Length 150.0 mm | In distribution | |
| 171151-27A | Length 150.0 mm | In distribution | |
| 031151-29B | Length 90.0 mm | In distribution | |
| 021151-30C | Outer Diameter 0.7 mm | In distribution | |
| 131151-30C | Outer Diameter 0.7 mm | In distribution | |
| 021151-29A | Outer Diameter 0.5 mm | In distribution | |
| 051151-29A | Length 120.0 mm | In distribution | |
| 161151-29A | Length 103.0 mm | In distribution | |
| 151151-29A | Outer Diameter 0.5 mm | In distribution | |
| 021151-30A | Outer Diameter 0.55 mm | In distribution | |
| 031151-31A | In distribution | ||
| 171151-29A | Outer Diameter 0.5 mm | In distribution | |
| 041163-30A | Length 120.0 mm | 10 | Withdrawn |
| 131163-30C | Length 120.0 mm | 10 | Withdrawn |
| 021163-29A | Length 90.0 mm | 25 | Withdrawn |
| 521151-29A | 25 | Withdrawn | |
| 041151-29A | Outer Diameter 0.5 mm | 25 | Withdrawn |
| 321163-31A | Outer Diameter 0.8 mm | 25 | Withdrawn |
| 021151-30A | Length 103.0 mm | 25 | Withdrawn |
| 041251-30A | Outer Diameter 0.55 mm | 10 | Withdrawn |
| 0051151-30 | Length 200.0 mm | 10 | Withdrawn |
| 021151-29E | 25 | Withdrawn | |
| 031163-27A | Outer Diameter 0.4 mm | 10 | Withdrawn |
| 121251-30A | Outer Diameter 0.55 mm | 25 | Withdrawn |
| 001151-31A | Outer Diameter 0.8 mm | 25 | Withdrawn |
| 021151-29B | Length 70.0 mm | 25 | Withdrawn |
| 521151-30C | Length 103.0 mm | 25 | Withdrawn |
| 021151-30B | Length 70.0 mm | 25 | Withdrawn |
| 141163-30C | Outer Diameter 0.7 mm | 10 | Withdrawn |
| 041163-27A | Length 103.0 mm | 25 | Withdrawn |
| 041151-30C | Outer Diameter 0.7 mm | 10 | Withdrawn |
| 031151-30C | Length 120.0 mm | 10 | Withdrawn |
| 211163-27A | Outer Diameter 0.4 mm | 25 | Withdrawn |
| 071151-30C | Outer Diameter 0.7 mm | 25 | Withdrawn |
| 501163-29A | Length 90.0 mm | 25 | Withdrawn |
| 261163-29A | Length 150.0 mm | 10 | Withdrawn |
| 121163-30A | Length 90.0 mm | 25 | Withdrawn |
| 001151-29E | Outer Diameter 0.5 mm | 25 | Withdrawn |
| 051151-30B | Outer Diameter 0.7 mm | 25 | Withdrawn |
| 0041151-31 | Outer Diameter 0.9 mm | 10 | Withdrawn |
| 041151-30A | Outer Diameter 0.55 mm | 10 | Withdrawn |
| 021151-30F | Length 50.0 mm | 25 | Withdrawn |
| 021151-30F | Length 50.0 mm | 25 | Withdrawn |
| 021151-29B | Length 70.0 mm | 25 | Withdrawn |
| 041251-29A | Length 103.0 mm | 25 | Withdrawn |
| 171151-29A | 10 | Withdrawn | |
| 321151-30C | Outer Diameter 0.7 mm | 25 | Withdrawn |
| 041151-30A | 10 | Withdrawn | |
| 051151-30C | Length 70.0 mm | 25 | Withdrawn |
| 331151-31B | Outer Diameter 0.9 mm | 25 | Withdrawn |
| 001163-30D | Outer Diameter 0.55 mm | 25 | Withdrawn |
| 0061151-31 | Outer Diameter 0.9 mm | 10 | Withdrawn |
| 071151-30A | Outer Diameter 0.55 mm | 10 | Withdrawn |
| 021151-30B | Outer Diameter 0.55 mm | 25 | Withdrawn |
| 051151-29A | Outer Diameter 0.5 mm | 10 | Withdrawn |
| 211163-29A | Outer Diameter 0.5 mm | 25 | Withdrawn |
| 501185-29A | Length 90.0 mm | 25 | Withdrawn |
| 061151-29A | 25 | Withdrawn | |
| 501163-29A | Outer Diameter 0.5 mm | 25 | Withdrawn |
| 031151-30A | Outer Diameter 0.55 mm | 10 | Withdrawn |
| 001151-29E | 25 | Withdrawn | |
| 131163-30C | Outer Diameter 0.7 mm | 10 | Withdrawn |
| 121251-30A | Outer Diameter 0.55 mm | 25 | Withdrawn |
| 041163-27A | Outer Diameter 0.4 mm | 25 | Withdrawn |
| 511151-29A | Length 90.0 mm | 25 | Withdrawn |
| 061151-30C | Outer Diameter 0.7 mm | 25 | Withdrawn |
| 021163-30A | Length 103.0 mm | 25 | Withdrawn |
| 121151-27B | Outer Diameter 0.4 mm | 25 | Withdrawn |
| 151251-29A | Length 123.0 mm | 10 | Withdrawn |
| 331151-31A | Outer Diameter 0.8 mm | Withdrawn | |
| 021163-27A | Length 90.0 mm | 25 | Withdrawn |
| 0051163-30 | Length 200.0 mm | 10 | Withdrawn |
| 021163-30C | Length 90.0 mm | 25 | Withdrawn |
| 521151-30C | 25 | Withdrawn | |
| 021151-30A | Outer Diameter 0.55 mm | 25 | Withdrawn |
| 231163-27A | Length 120.0 mm | 10 | Withdrawn |
| 0041151-30 | Length 200.0 mm | 10 | Withdrawn |
| 151151-27A | 10 | Withdrawn | |
| 021151-29B | 25 | Withdrawn | |
| 031251-30A | Length 120.0 mm | 10 | Withdrawn |
| 0051151-30 | 10 | Withdrawn | |
| 051163-29A | Length 120.0 mm | 10 | Withdrawn |
| 221163-30C | Outer Diameter 0.7 mm | 25 | Withdrawn |
| 041152-30C | Length 150.0 mm | 10 | Withdrawn |
| 001151-30D | 25 | Withdrawn | |
| 041163-29A | Length 103.0 mm | 25 | Withdrawn |
| 501185-29A | Outer Diameter 0.5 mm | 25 | Withdrawn |
| 061163-29A | Length 150.0 mm | 10 | Withdrawn |
| 501151-28A | 25 | Withdrawn | |
| 151251-27A | Outer Diameter 0.4 mm | 10 | Withdrawn |
| 131163-30A | Outer Diameter 0.55 mm | 10 | Withdrawn |
| 521151-30A | Outer Diameter 0.55 mm | 25 | Withdrawn |
| 161151-29A | 25 | Withdrawn | |
| 0041151-31 | Length 150.0 mm | 10 | Withdrawn |
| 061151-30C | 25 | Withdrawn | |
| 041151-30A | Outer Diameter 0.55 mm | 10 | Withdrawn |
| 001151-30A | 25 | Withdrawn | |
| 0041151-30 | 10 | Withdrawn | |
| 031163-29A | Outer Diameter 0.5 mm | 10 | Withdrawn |
| 031151-30C | Outer Diameter 0.7 mm | 10 | Withdrawn |
| 061251-29A | Outer Diameter 0.5 mm | 10 | Withdrawn |
| 161151-27A | Length 103.0 mm | 25 | Withdrawn |
| 041151-29A | 25 | Withdrawn | |
| 061151-30C | Length 25.0 mm | 25 | Withdrawn |
| 021251-30A | Length 103.0 mm | 25 | Withdrawn |
| 051151-30B | 25 | Withdrawn | |
| 031152-30C | Length 120.0 mm | 10 | Withdrawn |
| 511151-29A | 25 | Withdrawn | |
| 001151-30E | Outer Diameter 0.55 mm | 25 | Withdrawn |
| 021251-29A | Length 90.0 mm | 25 | Withdrawn |
| 141251-27A | Length 103.0 mm | 25 | Withdrawn |
| 021151-29E | Length 35.0 mm | 25 | Withdrawn |
| 041152-30C | 10 | Withdrawn | |
| 041152-30C | Outer Diameter 0.7 mm | 10 | Withdrawn |
| 0061151-31 | Outer Diameter 0.9 mm | 10 | Withdrawn |
| 121163-30A | Outer Diameter 0.55 mm | Withdrawn | |
| 141151-30C | 10 | Withdrawn | |
| 221151-30C | Outer Diameter 0.7 mm | 25 | Withdrawn |
| 331151-30C | Length 120.0 mm | 25 | Withdrawn |
| 051251-29A | Length 120.0 mm | 10 | Withdrawn |
| 001151-30B | Outer Diameter 0.55 mm | 25 | Withdrawn |
| 021163-27A | Outer Diameter 0.4 mm | 25 | Withdrawn |
| 151251-29A | Outer Diameter 0.5 mm | 10 | Withdrawn |
| 071151-30C | 25 | Withdrawn | |
| 061163-29A | Outer Diameter 0.5 mm | 10 | Withdrawn |
| 031251-30A | Length 120.0 mm | 10 | Withdrawn |
| 221163-30C | Outer Diameter 0.7 mm | 25 | Withdrawn |
| 121151-27A | Outer Diameter 0.4 mm | 25 | Withdrawn |
| 131151-30C | Outer Diameter 0.7 mm | 10 | Withdrawn |
| 171151-27A | Outer Diameter 0.4 mm | 10 | Withdrawn |
| 031151-30C | 10 | Withdrawn | |
| 161151-27A | Length 103.0 mm | 25 | Withdrawn |
| 001152-30C | Length 90.0 mm | 25 | Withdrawn |
| 121251-27A | Outer Diameter 0.4 mm | 25 | Withdrawn |
| 361151-31B | Length 150.0 mm | 10 | Withdrawn |
| 031151-29A | 10 | Withdrawn | |
| 321151-31C | Length 90.0 mm | 25 | Withdrawn |
| 051151-30C | 25 | Withdrawn | |
| 071151-30C | Length 50.0 mm | 25 | Withdrawn |
| 321151-29A | Length 90.0 mm | 25 | Withdrawn |
| 001251-30A | Length 90.0 mm | 25 | Withdrawn |
| 421151-31A | Length 90.0 mm | 25 | Withdrawn |
| 031163-27A | Outer Diameter 0.4 mm | 10 | Withdrawn |
| 031151-29A | Outer Diameter 0.5 mm | 10 | Withdrawn |
| 021251-29A | Length 90.0 mm | 25 | Withdrawn |
| 501251-29A | Outer Diameter 0.5 mm | 25 | Withdrawn |
| 231163-27A | Length 120.0 mm | 10 | Withdrawn |
| 221151-30C | 25 | Withdrawn | |
| 141151-30A | 10 | Withdrawn | |
| 121151-30A | Length 90.0 mm | 25 | Withdrawn |
| 151151-29A | 10 | Withdrawn | |
| 231251-27A | Outer Diameter 0.4 mm | 10 | Withdrawn |
| 021151-29A | 25 | Withdrawn | |
| 171151-29A | Outer Diameter 0.5 mm | 10 | Withdrawn |
| 001151-30B | 25 | Withdrawn | |
| 121151-30A | 25 | Withdrawn | |
| 021185-29A | 25 | Withdrawn | |
| 051151-30B | Length 70.0 mm | 25 | Withdrawn |
| 141151-27A | Outer Diameter 0.4 mm | 25 | Withdrawn |
| 261163-29A | Length 150.0 mm | 10 | Withdrawn |
| 231151-27A | Length 123.0 mm | 10 | Withdrawn |
| 521151-29A | Outer Diameter 0.5 mm | 25 | Withdrawn |
| 021151-30C | 25 | Withdrawn | |
| 061251-29A | Outer Diameter 0.5 mm | 10 | Withdrawn |
| 511151-29A | Outer Diameter 0.5 mm | 25 | Withdrawn |
| 161151-29A | Length 103.0 mm | 25 | Withdrawn |
| 171151-27A | Outer Diameter 0.4 mm | 10 | Withdrawn |
| 341151-31B | Outer Diameter 0.9 mm | 25 | Withdrawn |
| 001151-30C | 25 | Withdrawn | |
| 061151-29A | Length 150.0 mm | 25 | Withdrawn |
| 501151-29A | Outer Diameter 0.5 mm | 25 | Withdrawn |
| 031251-29A | Outer Diameter 0.5 mm | 10 | Withdrawn |
| 321151-31A | Outer Diameter 0.8 mm | 25 | Withdrawn |
| 041151-29A | Outer Diameter 0.5 mm | 25 | Withdrawn |
| 041151-30C | 10 | Withdrawn | |
| 151151-29A | Outer Diameter 0.5 mm | 10 | Withdrawn |
| 00115230CB | 10 | Withdrawn | |
| 031163-29A | Outer Diameter 0.5 mm | 10 | Withdrawn |
| 121251-27A | Outer Diameter 0.4 mm | 25 | Withdrawn |
| 521151-30A | 25 | Withdrawn | |
| 021151-30A | 25 | Withdrawn | |
| 021151-30F | 25 | Withdrawn | |
| 051163-29A | Outer Diameter 0.5 mm | 10 | Withdrawn |
| 021185-29A | 25 | Withdrawn | |
| 141151-27A | 25 | Withdrawn | |
| 341151-31A | Length 103.0 mm | 25 | Withdrawn |
| 171151-27A | 10 | Withdrawn | |
| 211163-27A | Length 90.0 mm | 25 | Withdrawn |
| 001151-30A | Length 90.0 mm | 25 | Withdrawn |
| 001163-29E | Length 35.0 mm | 25 | Withdrawn |
| 141163-30C | Outer Diameter 0.7 mm | 10 | Withdrawn |
| 061151-29A | Outer Diameter 0.5 mm | 25 | Withdrawn |
| 031152-30C | Length 120.0 mm | 10 | Withdrawn |
| 051151-29A | Length 120.0 mm | 10 | Withdrawn |
| 021151-30C | Length 90.0 mm | 25 | Withdrawn |
| 501151-29A | 25 | Withdrawn | |
| 021251-30A | Outer Diameter 0.55 mm | 25 | Withdrawn |
| 051251-29A | Outer Diameter 0.5 mm | 10 | Withdrawn |
| 071151-30A | Outer Diameter 0.55 mm | 10 | Withdrawn |
| 021151-29E | Length 35.0 mm | 25 | Withdrawn |
| 00115230CB | Outer Diameter 0.7 mm | 10 | Withdrawn |
| 001152-30C | 25 | Withdrawn | |
| 231151-27A | 10 | Withdrawn | |
| 141151-30C | Length 150.0 mm | 10 | Withdrawn |
| 321151-31B | Outer Diameter 0.9 mm | 25 | Withdrawn |
| 001163-30A | Length 90.0 mm | 25 | Withdrawn |
| 021163-30A | Length 103.0 mm | 25 | Withdrawn |
| 501251-29A | Outer Diameter 0.5 mm | 25 | Withdrawn |
| 501151-28A | Length 90.0 mm | 25 | Withdrawn |
| 121151-27A | 25 | Withdrawn | |
| 031151-29A | Length 120.0 mm | 10 | Withdrawn |
| 131163-30A | Length 150.0 mm | 10 | Withdrawn |
| 041163-30A | Length 120.0 mm | 10 | Withdrawn |
| 211163-29A | Outer Diameter 0.5 mm | 25 | Withdrawn |
| 0041151-30 | Length 200.0 mm | 10 | Withdrawn |
| 001151-30E | 25 | Withdrawn | |
| 031151-30A | 10 | Withdrawn | |
| 121151-27B | 25 | Withdrawn | |
| 131151-30A | 10 | Withdrawn | |
| 071151-30A | 10 | Withdrawn | |
| 041163-29A | Outer Diameter 0.5 mm | 25 | Withdrawn |
| 041151-30C | Length 150.0 mm | 10 | Withdrawn |
| 031251-29A | Outer Diameter 0.5 mm | 10 | Withdrawn |
Showing 250 of 273 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Halyard | Avanos Medical, Inc. | 386 |
| 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 |
| 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.