Epimed
Spirol® Block 20g x 24" Continuous Peripheral Nerve Block Catheter
1manufacturer
56catalogue numbers in this listing
4510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
Record
| Listed by | Epimed International, Inc., United States |
|---|---|
| FDA product code | BSO |
| Device type | Catheter, Conduction, Anesthetic |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5120 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K981329 |
| Record published | 2017-10-24 |
| Record revised | 2023-08-21 (version 8) |
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, pack of 10 |
| Sizes | Length 3.5 to 36 in; catheter gauge 1.7 to 3.2 Fr; catheter length 14 in; needle gauge 16 G |
| Distribution end date | 2025-04-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 164-2014 | Catheter Length 14 in | In distribution |
| 169-2412 | 12″ | In distribution |
| 155-2350 | Length 14 in | In distribution |
| 153-2540 | 19g | In distribution |
| 202-1936 | 19g | In distribution |
| 158-2114 | 14.0″ | In distribution |
| 201-2430 | 24g | In distribution |
| 159-2124 | 21g | In distribution |
| 165-1936 | 19g | In distribution |
| 165-2036 | 21g | In distribution |
| 166-2024 | 21g | In distribution |
| 155-2340 | Catheter Gauge 3.2 Fr | In distribution |
| 194-2036 | 36″ | In distribution |
| 200-2430 | Length 30 in | In distribution |
| 156-2124 | Catheter Gauge 2.4 Fr | In distribution |
| 155-2540 | Catheter Gauge 3.2 Fr | In distribution |
| 155-2550 | Length 24 in | In distribution |
| 168-2014 | 21g | In distribution |
| 155-1520 | Catheter Gauge 3.2 Fr | In distribution |
| 157-1924 | 24″ | In distribution |
| 156-2118 | Catheter Gauge 2.4 Fr | In distribution |
| 155-2343 | Length 14 in | In distribution |
| 155-2393 | 14″ | In distribution |
| 156-2112 | 12″ | In distribution |
| 164-1936 | 19g | In distribution |
| 155-2542 | Catheter Gauge 3.2 Fr | In distribution |
| 166-1936 | 19g | In distribution |
| 154-1912 | Length 12 in | In distribution |
| 166-2036 | Length 36 in | In distribution |
| 155-2342 | Catheter Gauge 3.2 Fr | In distribution |
| 193-2036 | Catheter Gauge 2.7 Fr | In distribution |
| 153-2340 | 14 [in_i] | In distribution |
| 202-2036 | Catheter Gauge 2.7 Fr | In distribution |
| 159-2112 | 12 [in_i] | In distribution |
| 164-2024 | Catheter Gauge 2.7 Fr | In distribution |
| 192-2024 | 21g | Withdrawn |
| 170-2124 | Length 24 in | Withdrawn |
| 195-1936 | 36″ | Withdrawn |
| 175-2024 | Length 24 in | Withdrawn |
| 174-1924 | Length 24 in | Withdrawn |
| 164-1936T | 36″ | Withdrawn |
| 181-2540 | Catheter Gauge 3.2 Fr | Withdrawn |
| 157-1912 | Catheter Gauge 3.2 Fr | Withdrawn |
| 179-2340 | 4.0″ | Withdrawn |
| 176-1924 | 19g | Withdrawn |
| 175-1924 | 24″ | Withdrawn |
| 171-2124 | Catheter Gauge 2.4 Fr | Withdrawn |
| 154-1924 | 19g x 24″ | Withdrawn |
| 176-2024 | Length 24 in | Withdrawn |
| 174-2024 | 24″ | Withdrawn |
| 194-2024 | Length 24 in | Withdrawn |
| 193-2024 | Catheter Gauge 2.7 Fr | Withdrawn |
| 155-1353 | 19g | Withdrawn |
| 173-1924 | Catheter Gauge 3.2 Fr | Withdrawn |
| 173-2024 | 24″ | Withdrawn |
| 156-2136 | 21g | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 366 |
| Avanos | Avanos Medical, Inc. | 48 |
| E-Cath Tsui | Pajunk Gmbh Medizintechnologie | 47 |
| Halyard | Avanos Medical, Inc. | 34 |
| Infiltralong | Pajunk Gmbh Medizintechnologie | 25 |
| E-Cath acc. Tsui | Pajunk Gmbh Medizintechnologie | 21 |
| E-Cath Plus acc. Tsui | Pajunk Gmbh Medizintechnologie | 17 |
| Epinaut | Imedicom Co., Ltd. | 16 |
| E-Cath® Plus Tsui® | Pajunk Gmbh Medizintechnologie | 10 |
| E-Cath® II Tsui® | Pajunk Gmbh Medizintechnologie | 9 |
| Spinaut-E | Imedicom Co., Ltd. | 9 |
| E-Cath® NRFit Tsui® | Pajunk Gmbh Medizintechnologie | 6 |
Showing 12 of 65. All products under Catheter, Conduction, Anesthetic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200624 | 2020-04-27 |
| K133316 | 2014-05-28 |
| K023140 | 2003-08-15 |
| K981329 | 1998-08-26 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, 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 | 2021-02-01 | Class II | Process control | Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off | 5835 units | 2022-10-17 |
| Epimed International, Inc. | 510(k) number | 2019-06-18 | Class II | Labeling mix-ups | Mislabeled – The product’s labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included. | 200 kits | |
| Epimed International, Inc. | 510(k) number | 2019-06-18 | Class II | Labeling mix-ups | Mislabeled – The product’s labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included. | 98 kits | |
| Epimed International, Inc. | 510(k) number | 2017-12-28 | Class II | Process control | Potential for stylet to protrude from the distal end of the catheter | 132 units | |
| Epimed International, Inc. | 510(k) number | 2017-12-28 | Class II | Process control | Potential for stylet to protrude from the distal end of the catheter | 140 units |
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.