Solero
Microwave Tissue Ablation Applicator
10manufacturers in China registered for this device type
5catalogue numbers in this listing
5510(k) clearances naming this product code
15recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (2), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Canyon Medical Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Hygea Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Betters(Suzhou) Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
| Nanjing Devin Medical Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 1 |
| ECO Medical Technology (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 1 |
| Mima-PRO (NAN Tong) Scientific Inc. | Nantong | Jiangsu | Manufacturer | 1 |
Record
| Listed by | AngioDynamics, Inc., United States |
|---|---|
| FDA product code | NEY |
| Device type | System, Ablation, Microwave And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K162449 |
| Record published | 2017-05-10 |
| Record revised | 2021-10-26 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 85 % RH; Storage environment temperature -29 to 60 °C |
| Sizes | Length 14 to 29 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 700106002-US | Length 19 cm | In distribution |
| 700106003-US | Length 29 cm | In distribution |
| 12740000US | In distribution | |
| H787127401380 | In distribution | |
| 700106001-US | Length 14 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Microwave Ablation Antennas | Canyon Medical Inc. | 66 |
| Neuwave | Neuwave Medical, Inc. | 25 |
| ECO Disposable microwave therapeutic antenna | ECO Medical Technology (Nanjing) Co., Ltd. | 21 |
| Hygea | Hygea Medical Technology Co., Ltd. | 18 |
| Avecure | MedWaves, Inc | 17 |
| Certus® 140 | Neuwave Medical, Inc. | 17 |
| Emprint | Covidien LP | 14 |
| Betters (Suzhou)Medical Co., Ltd. | Betters(Suzhou) Medical Co., Ltd. | 11 |
| Emprint SX | Covidien LP | 11 |
| Mima-Pro | Mima-PRO (NAN Tong) Scientific Inc. | 10 |
| Dophi | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 9 |
| Evident | Covidien LP | 8 |
Showing 12 of 55. All products under System, Ablation, Microwave And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223581 | 2023-03-27 |
| K221883 | 2023-03-07 |
| K213067 | 2021-12-03 |
| K182250 | 2019-02-28 |
| K162449 | 2017-05-05 |
Recalls Naming This Product
9 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 |
|---|---|---|---|---|---|---|---|
| AngioDynamics, Inc. | 510(k) number | 2021-07-20 | Class II | Software design | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up. | 16 US, 2 OUS | 2023-03-15 |
| AngioDynamics, Inc. | 510(k) number | 2021-07-20 | Class II | Software design | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up. | 26 US, 4 OUS | 2023-03-15 |
| AngioDynamics, Inc. | 510(k) number | 2021-07-20 | Class II | Software design | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up. | 8 OUS | 2023-03-15 |
| AngioDynamics, Inc. | 510(k) number | 2021-07-20 | Class II | Software design | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up. | 65 OUS | 2023-03-15 |
| AngioDynamics, Inc. | 510(k) number | 2019-04-17 | Class II | Device Design | Updated Warning Statements in the Operator’s Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure | 314 units | 2020-06-09 |
| AngioDynamics, Inc. | 510(k) number | 2019-04-17 | Class II | Device Design | Updated Warning Statements in the Operator’s Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure | 178 units | 2020-06-09 |
| AngioDynamics, Inc. | 510(k) number | 2019-04-17 | Class II | Device Design | Updated Warning Statements in the Operator’s Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure | 10580 | 2020-06-09 |
| AngioDynamics, Inc. | 510(k) number | 2019-04-17 | Class II | Device Design | Updated Warning Statements in the Operator’s Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure | 7348 | 2020-06-09 |
| AngioDynamics, Inc. | 510(k) number | 2019-04-17 | Class II | Device Design | Updated Warning Statements in the Operator’s Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure | 1846 | 2020-06-09 |
Recalls
6 of these are 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 | Closed |
|---|---|---|---|---|---|
| 2017-06-05 | Class II | Under Investigation by firm | The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results | 14,353 units in total | 2018-09-11 |
| 2017-06-05 | Class II | Under Investigation by firm | The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results | 14,353 units in total | 2018-09-11 |
| 2017-06-05 | Class II | Under Investigation by firm | The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results | 14,353 units in total | 2018-09-11 |
| 2017-06-05 | Class II | Under Investigation by firm | The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results | 14,353 units in total | 2018-09-11 |
| 2017-06-05 | Class II | Under Investigation by firm | The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results | 14,353 units in total | 2018-09-11 |
| 2017-06-05 | Class II | Under Investigation by firm | The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results | 14,353 units in total | 2018-09-11 |
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.