NanoKnife
NanoKnife Disposable Single Electrode 5 Probe Pack - Activation
4manufacturers in China registered for this device type
25catalogue numbers in this listing
5510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Zhejiang (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Energenx Medical Ltd. | Shanghai | Shanghai | Contract manufacturer | 2 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Zhejiang Curaway Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
Record
| Listed by | AngioDynamics, Inc., United States |
|---|---|
| FDA product code | OAB |
| Device type | Low Energy Direct Current Thermal Ablation System |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K150089 |
| Record published | 2016-09-21 |
| Record revised | 2022-10-10 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature up to 27 °C |
| Packaging | Box of 10 |
| Sizes | Length 15 to 25 cm |
| Distribution end date | 2026-04-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20400107 | Length 15 cm | In distribution |
| 20300101 | In distribution | |
| H787204001110 | Length 15 cm | In distribution |
| 20300101-US | In distribution | |
| 20400106 | Length 25 cm | In distribution |
| H78720300301US0 | In distribution | |
| 20400105 | Length 25 cm | In distribution |
| H78720300351US0 | In distribution | |
| H787204003010 | In distribution | |
| 20400103 | Length 15 cm | In distribution |
| H787204001090 | Length 15 cm | In distribution |
| 20400108 | Length 25 cm | In distribution |
| 20400104 | Length 15 cm | In distribution |
| H787204001100 | Length 25 cm | In distribution |
| 20400110 | Length 25 cm | Withdrawn |
| 20400109 | Length 15 cm | Withdrawn |
| 20400101 | Length 15 cm | Withdrawn |
| 20300301US | Withdrawn | |
| 20400103 | Length 15 cm | Withdrawn |
| 20400301 | Withdrawn | |
| 20400111 | Length 15 cm | Withdrawn |
| 20400104 | Length 15 cm | Withdrawn |
| 20400102 | Length 25 cm | Withdrawn |
| 20400106 | Length 25 cm | Withdrawn |
| 20400105 | Length 25 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Curaway | Zhejiang Curaway Medical Technology Co., Ltd. | 25 |
| Dophi | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 8 |
| Aliya Needle | Galvanize Therapeutics | 2 |
| Aliya Generator | Galvanize Therapeutics | 1 |
| Aliya Electrode | Galvanize Therapeutics | 1 |
| US Medical Innovations | US Medical Innovations, LLC | 1 |
| Aliya PEF Ablation Pack | Galvanize Therapeutics | 1 |
| Aliya Generator-Recertified | Galvanize Therapeutics | 1 |
| Inumi Flex Needle | Galvanize Therapeutics | 1 |
| Inumi Flex Needle Pack | Galvanize Therapeutics | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253198 | 2026-03-24 |
| K242687 | 2024-12-06 |
| K183385 | 2019-06-18 |
| K150089 | 2015-06-18 |
| K102329 | 2011-10-24 |
Recalls Naming This Product
2 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 | 2023-03-02 | Class II | Under Investigation by firm | Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure | 10 boxes( 5 probes/box) | |
| AngioDynamics, Inc. | 510(k) number | 2020-04-24 | Class II | Software Manufacturing/Software Deployment | Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator. | 37 | 2022-09-20 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-04-04 | Not classified | Component design/selection | Some units of Nanoknife have the potential to deliver a shortened pulse width without indicating an error. The affected units contain a “GOMe” circuit board which may cause the generator to drift from the calibration points set at the time | 21 units | 2016-01-29 |
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.