Epimed
RX Coudé® Epidural Needle with Small Bore Connection 16g TW x 4.5"
9manufacturers in China registered for this device type
131catalogue numbers in this listing
6510(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 | Epimed International, Inc., United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| 510(k) | K041843 |
| Record published | 2017-10-20 |
| Record revised | 2024-06-04 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature 50 to 90 °F |
| Packaging | Case of 10, case of 25, pack of 10 |
| Sizes | Length 1.5 to 8 in; needle gauge 12 to 25 G |
| Distribution end date | 2025-04-08 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 122-2060 | Needle Gauge 20 G | In distribution |
| 125-2045T | 20g TW | In distribution |
| 107-1416 | Needle Gauge 16 G | In distribution |
| 108-1516 | Length 4.5 in | In distribution |
| 130-2245 | Needle Gauge 22 G | In distribution |
| 117-2535 | 3.5″ | In distribution |
| 116-2230 | Length 3 in | In distribution |
| 120-2535 | 25g RW | In distribution |
| 126-2025 | Length 2.5 in | In distribution |
| 107-1314 | 14g TW | In distribution |
| 107-1618 | Length 6 in | In distribution |
| 116-2525 | 25g RW | In distribution |
| 121-2245 | Needle Gauge 22 G | In distribution |
| 125-1635T | Length 3.5 in | In distribution |
| 118-2045 | 20g TW | In distribution |
| 116-2245 | 22g RW | In distribution |
| 116-2270 | Length 7.0 in | In distribution |
| 125-2235T | Needle Gauge 22 G | In distribution |
| 130-2545 | Needle Gauge 25 G | In distribution |
| 107-1415 | 15g RW | In distribution |
| 105-1416 | Length 3.5 in | In distribution |
| 117-2260 | Needle Gauge 22 G | In distribution |
| 106-1712 | Needle Gauge 12 G | In distribution |
| 109-1613 | Needle Gauge 13 G | In distribution |
| 100-1416 | 3.5″ | In distribution |
| 107-1616 | Needle Gauge 13 G | In distribution |
| 131-2535 | Length 3.5 in | In distribution |
| 120-2525 | 25g RW | In distribution |
| 131-2060 | 20g | In distribution |
| 116-2045 | 4.5″ | In distribution |
| 116-2260 | 6.0″ | In distribution |
| 121-2235 | Length 3.5 in | In distribution |
| 121-2225 | Length 2.5 in | In distribution |
| 126-2035 | 20g | In distribution |
| 125-2035T | 3.5″ | In distribution |
| 105-1515 | 4.5″ | In distribution |
| 100-1415 | Needle Gauge 15 G | In distribution |
| 125-2060T | 20g TW | In distribution |
| 125-1735T | 17g TW | In distribution |
| 131-2545 | 4.5 [in_i] | In distribution |
| 123-2215 | 1.5″ | In distribution |
| 116-2080 | Length 8 in | In distribution |
| 120-2235 | 22g RW | In distribution |
| 120-2225 | Needle Gauge 22 G | In distribution |
| 126-1860 | 18g | In distribution |
| 130-2535 | 25g TW | In distribution |
| 123-2028 | 6″ | In distribution |
| 106-1615 | 15g RW | In distribution |
| 106-1616 | Needle Gauge 16 G | In distribution |
| 105-1613 | 6.0″ | In distribution |
| 115-2280 | Needle Gauge 22 G | In distribution |
| 126-2060 | 6.0 [in_i] | In distribution |
| 117-2060 | 20g TW | In distribution |
| 126-2045 | Needle Gauge 20 G | In distribution |
| 105-1616 | Length 6 in | In distribution |
| 126-1835 | 3.5 [in_i] | In distribution |
| 136-1730 | Length 3 in | In distribution |
| 105-1313 | Length 4 in | In distribution |
| 117-2045 | 20g TW | In distribution |
| 126-1845 | 18g | In distribution |
| 125-1835T | 3.5″ | In distribution |
| 105-1615 | Needle Gauge 15 G | In distribution |
| 106-1518 | 4.5″ | In distribution |
| 131-2235 | Length 3.5 in | In distribution |
| 106-1313 | 13g TW | In distribution |
| 107-1614 | 6.0″ | In distribution |
| 115-2235 | 3.5″ | In distribution |
| 108-1415 | Needle Gauge 15 G | In distribution |
| 123-2020 | Length 2.0 in | In distribution |
| 196-3020 | Needle Gauge 20 G | In distribution |
| 107-1313 | Needle Gauge 13 G | In distribution |
| 131-2245 | 22g | In distribution |
| 116-2220 | Needle Gauge 22 G | In distribution |
| 126-1825 | 18g | In distribution |
| 100-1417 | 17g XTW | In distribution |
| 106-1618 | 18g TW | In distribution |
| 106-1418 | 18g TW | In distribution |
| 126-2235 | Length 3.5 in | In distribution |
| 126-2225 | 2.5 [in_i] | In distribution |
| 116-2035 | Length 3.5 in | In distribution |
| 196-3018 | Length 3.5 in | In distribution |
| 126-1760 | Length 6 in | In distribution |
| 106-1312 | 12g TW | In distribution |
| 105-1415 | Length 3.5 in | In distribution |
| 116-2535 | Needle Gauge 25 G | In distribution |
| 106-1516 | Needle Gauge 16 G | In distribution |
| 105-1518 | Length 4.5 in | In distribution |
| 105-1314 | 14g TW | In distribution |
| 119-2080 | 8.0in | In distribution |
| 131-2225 | Length 2.5 in | In distribution |
| 107-1613 | Length 6 in | In distribution |
| 115-2260 | 6.0″ | In distribution |
| 106-1416 | 16g TW | In distribution |
| 116-2060 | Length 6 in | In distribution |
| 131-2260 | Needle Gauge 22 G | In distribution |
| 125-1860T | Needle Gauge 18 G | In distribution |
| 105-1516 | 4.5″ | In distribution |
| 120-2245 | 22g RW | In distribution |
| 100-1516 | 16g TW | In distribution |
| 116-2020 | Length 2.0 in | In distribution |
| 122-2080 | Needle Gauge 20 G | In distribution |
| 105-1618 | Length 6 in | In distribution |
| 121-2525 | 2.5″ | In distribution |
| 116-2235 | Length 3.5 in | In distribution |
| 105-1614 | 6.0″ | In distribution |
| 108-1416 | 16g | In distribution |
| 121-2535 | Length 3.5 in | In distribution |
| 106-1613 | 13g TW | In distribution |
| 117-2230 | Needle Gauge 22 G | In distribution |
| 107-1418 | 18g TW | In distribution |
| 105-1712 | Needle Gauge 12 G | In distribution |
| 105-1218 | 2.5″ | In distribution |
| 108-1418 | Length 3.5 in | In distribution |
| 196-3022 | Needle Gauge 22 G | In distribution |
| 105-1418 | 18g TW | In distribution |
| 106-1314 | 14g TW | In distribution |
| 118-2060 | 20g TW | In distribution |
| 117-2080 | Needle Gauge 20 G | In distribution |
| 109-1413 | Length 4 in | In distribution |
| 126-1735 | Length 3.5 in | In distribution |
| 117-2245 | 22g RW | In distribution |
| 126-1635 | 3.5 [in_i] | In distribution |
| 189-2340 | 4.0″ | Withdrawn |
| 188-2340 | 4.0″ | Withdrawn |
| 106-1415 | Needle Gauge 15 G | Withdrawn |
| 125-1820T | 2.0in | Withdrawn |
| 189-2260 | 22g | Withdrawn |
| 199-2340 | 6.0″ | Withdrawn |
| 188-2260 | Length 6 in | Withdrawn |
| 105-1312 | 5.0″ | Withdrawn |
| 106-1515 | Needle Gauge 15 G | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Halyard | Avanos Medical, Inc. | 386 |
| Sprotte® | Pajunk Gmbh Medizintechnologie | 273 |
| Avanos | Avanos Medical, Inc. | 264 |
| 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 |
|---|---|
| K072005 | 2008-02-07 |
| K053318 | 2006-02-17 |
| K043467 | 2005-03-31 |
| K041843 | 2004-08-24 |
| K030562 | 2003-04-03 |
| K022029 | 2002-07-30 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Epimed International, Inc. | 510(k) number | 2016-04-22 | Class II | Employee error | There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unneces | 576 units | 2018-06-14 |
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.