Agnes
by Agnes Medical Co., Ltd. 2 variants
Agnes is a Class II device made by Agnes Medical Co., Ltd., cleared under FDA 510(k) K203013 on 14 Jul 2022 and listed in FDA GUDID since 14 Jul 2023 (UDI-DI 18800067700009), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number18800067700009 | Date14 Jul 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK203013 | Date14 Jul 2022 | StatusActive |
Official records
- AccessGUDID record 18800067700009
- FDA 510(k) database K203013
Across registries
- FDA 510(k) K203013 decided 14 Jul 2022 Active
- FDA GUDID UDI-DI 18800067700009 listed 14 Jul 2023 Listed
Timeline
- Cleared FDA 510(k) K203013
- Listed FDA GUDID 18800067700009
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Intradermal radio-frequency ablation system
- Model / reference
- AGNES
- Primary DI / UDI-DI
- 18800067700009
- 510(k) Number
- FDA product code
- GEI, KCW
- GMDN term
- Intradermal radio-frequency ablation system
- Device class
- Class II
- Regulation number
- 878.4400, 878.5350
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).
- Guenter Bissinger Medizintechnik GmbH 80680162 by Günter Bissinger Medizintechnik GmbH
- DIEGO ELITE MDHP100A by Gyrus Acmi, Inc.
- Electrosurgical Meniscus Cutter Mod. AMC-100 by American Bentley
- Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle by Gyrus Acmi, Inc.
- truSculpt 2 MHz by CUTERA, INC.
- VIVA Combo RF System by STARMED CO., LTD
- Laparoscopic Instrument Grounding System by Conmedcorp
- CardioVations Optical Bipolar Device (K031846) by Ethicon Inc.
- Laparoscopic 5MM ABC Probe, Modification by Birtcher Medical Systems, Inc.
- Gimmi Z.1335.32 by Gimmi GmbH