Microwave Ablation System
by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
510(k) K183153
Microwave Ablation System is a medical device (FDA Class II; FDA product code NEY, System, Ablation, Microwave And Accessories) made by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd., cleared under FDA 510(k) K183153 on 8 Jul 2019, active as of 22 Oct 2026.
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK183153 | Date8 Jul 2019 | StatusActive |
Official records
- FDA 510(k) database K183153
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NEY
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K183153
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Dophi M150E | M150E | 06972304750292 | On the market | |
| Dophi SJ-B02 | SJ-B02 | 06972304751435 | On the market | |
| Dophi SS-MWA-1526C | SS-MWA-1526C | 16972304750268 | On the market | |
| Dophi SS-MWA-1531C | SS-MWA-1531C | 16972304750251 | On the market | |
| Dophi SS-MWA-2026C | SS-MWA-2026C | 16972304750275 | On the market | |
| Dophi SS-MWA-2031C | SS-MWA-2031C | 16972304750244 | On the market | |
| Dophi SS-MWA-2526C | SS-MWA-2526C | 16972304750282 | On the market | |
| Dophi SS-MWA-2531C | SS-MWA-2531C | 16972304750237 | On the market | |
| Dophi SS-TP18G-20 | SS-TP18G-20 | 16972304750015 | On the market |
Similar devices
Other devices filed under FDA product code NEY (System, Ablation, Microwave And Accessories).
- MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM by Medwaves Incorporated
- Creo Electrosurgical System with NP1 Instrument by Creo Medical, Ltd.
- Solero Microwave Tissue Ablation (MTA) System and Accessories by ANGIODYNAMICS, INC.
- Microwave Ablation System (BD-GT) by Betters(Suzhou) Medical Co., Ltd.
- Swift® Interconnect Cable SWF-CA01 by Emblation Limited
- Avecure 16-15-LH-15 by Medwaves Incorporated
- MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES by Bsd Medical Corp.
- NeuWave Microwave Ablation System and Accessories by NeuWave Medical, Inc.
- swiftPro™ System by Emblation Limited
- Certus 140 2.45GHz Ablation System by NeuWave Medical, Inc.
Other devices from Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
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