Accurian
Probe APSN150 Reuse Nitinl 150MM 16G-22G
1manufacturer
23catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | GXI |
| Device type | Probe, Radiofrequency Lesion |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4725 |
| 510(k) | K181864 |
| Record published | 2019-04-04 |
| Record revised | 2024-05-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Store between -20°C and 50°C |
| Packaging | Pack of 4 |
| Sizes | Length 50 to 150 mm; needle gauge 17 G |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| APSR150 | Length 150.0 mm | In distribution | |
| APSD100 | 4 | In distribution | |
| APSR100 | Length 100.0 mm | In distribution | |
| APSD050 | Length 50.0 mm | In distribution | |
| APSC05 | Length 100.0 mm | In distribution | |
| APSC02 | Needle Gauge 17.0 G | In distribution | |
| APSC07 | In distribution | ||
| APSN150 | Length 150.0 mm | In distribution | |
| APSR050 | Length 50.0 mm | In distribution | |
| APSC03 | Length 150.0 mm | In distribution | |
| APMT050 | In distribution | ||
| APSN100 | Length 100.0 mm | In distribution | |
| APSC06 | Needle Gauge 17.0 G | In distribution | |
| APSN050 | Length 50.0 mm | In distribution | |
| APSD150 | 4 | In distribution | |
| APSD050 | 4 | In distribution | |
| APSC09 | In distribution | ||
| APSD100 | Length 100.0 mm | In distribution | |
| APMT100 | In distribution | ||
| APMT150 | In distribution | ||
| APSC01 | Needle Gauge 17.0 G | In distribution | |
| APSD150 | Length 150.0 mm | In distribution | |
| APSC04 | Needle Gauge 17.0 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OWL | Diros Technology, Inc. | 345 |
| Probe, Radiofrequency Lesion | Boston Scientific Neuromodulation Corporation | 175 |
| Halyard | Avanos Medical, Inc. | 156 |
| Lccs | Lccs Products Limited | 101 |
| Epimed | Epimed International, Inc. | 100 |
| Avanos | Avanos Medical, Inc. | 89 |
| NeuroTherm™ | Neurotherm, Inc. | 87 |
| Probe, Radiofrequency Lesion | St. Jude Medical | 66 |
| cannulaRFK | Cosman Medical, Inc. | 56 |
| Rftl | Pajunk Gmbh Medizintechnologie | 54 |
| Radiofrequency (RF) Needle | Spectra Medical Devices, LLC | 49 |
| cannulaCC | Cosman Medical, Inc. | 47 |
Showing 12 of 85. All products under Probe, Radiofrequency Lesion
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 |
|---|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2020-06-08 | Class II | Under Investigation by firm | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | 481 pk | 2022-05-10 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2020-06-08 | Class II | Under Investigation by firm | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | 2415 pk | 2022-05-10 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2020-06-08 | Class II | Under Investigation by firm | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | 352 pk | 2022-05-10 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2020-06-08 | Class II | Under Investigation by firm | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | 5 pk | 2022-05-10 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2020-06-08 | Class II | Under Investigation by firm | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | 25 pk | 2022-05-10 |
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.