Emprint
Standard Percutaneous Antenna with Thermosphere (TM) Technology Large Spherical Ablation Zone - Reinforced Antenna
10manufacturers in China registered for this device type
14catalogue numbers in this listing
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 | Covidien LP, United States |
|---|---|
| FDA product code | NEY |
| Device type | System, Ablation, Microwave And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| 510(k) | K163105 |
| Record published | 2017-08-15 |
| Record revised | 2025-06-24 (version 19) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -22 to 158 °F; Storage environment humidity 10 to 90 % RH |
| Sizes | Length 15 to 30 cm |
| Distribution end date | 2025-06-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CAGEN1 | In distribution | |
| CA20L2 | Length 20 cm | In distribution |
| CA30L2 | Length 30 cm | In distribution |
| CAPUMP1 | In distribution | |
| CA20L2 | Length 20 cm | In distribution |
| CAGEN1ZD | In distribution | |
| CA20L1 | Length 20 cm | In distribution |
| CART1 | In distribution | |
| CA15L1 | Length 15 cm | In distribution |
| CA30L2 | Length 30 cm | In distribution |
| CAPUMP1ZD | In distribution | |
| CA15L2 | Length 15 cm | In distribution |
| CA30L1 | Length 30 cm | Withdrawn |
| CA30L1 | Length 30 cm | Withdrawn |
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 |
| 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 |
| SynchroWave Antenna Kit | Varian Medical Systems, Inc | 6 |
Showing 12 of 55. All products under System, Ablation, Microwave And Accessories
Recalls Naming This Product
9 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason |
|---|---|---|---|---|---|
| Covidien | 510(k) number | 2018-11-15 | Class II | Nonconforming Material/Component | The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient. |
| Covidien | 510(k) number | 2018-11-15 | Class II | Nonconforming Material/Component | The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient. |
| Covidien | 510(k) number | 2018-11-15 | Class II | Nonconforming Material/Component | The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient. |
| Covidien | UDI-DI | 2017-08-07 | Class II | Device Design | The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient. |
| Covidien | UDI-DI | 2017-08-07 | Class II | Device Design | The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient. |
| Covidien | UDI-DI | 2017-08-07 | Class II | Device Design | The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient. |
| Covidien | UDI-DI | 2017-08-07 | Class II | Device Design | The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient. |
| Covidien | UDI-DI | 2017-08-07 | Class II | Device Design | The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient. |
| Covidien | UDI-DI | 2017-08-07 | Class II | Device Design | The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient. |
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.