← Back to catalogue
star RF electrode-Fixed
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 16-30s25FRef 19-10s10FRef 15-15s40FRef 16-35s30FRef 17-15s20FRef 16-30s30FRef 15-25s30FRef 15-35s30FRef 18-15s05FTRef 18-15s10FRef 16-30s20FRef 18-07s15FTRef 18-10s07FTRef 18-15s30FRef 19-07s15FT
Identity
- Trade Name
- star RF electrode-Fixed EUDAMEDstar RF Electrode EUDAMEDFDA UDI
- Generic Name
- Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar FDA UDI
- Device Name
- star RF electrode-Fixed EUDAMEDstar RF Electrode EUDAMEDThe star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing. FDA UDI
- Model / Reference
- 16-30s25F EUDAMED19-10s10F EUDAMEDFDA UDI15-15s40F EUDAMED16-35s30F EUDAMED17-15s20F EUDAMEDFDA UDI16-30s30F EUDAMED15-25s30F EUDAMED15-35s30F EUDAMED18-15s05FT EUDAMED18-15s10F EUDAMED16-30s20F EUDAMED18-07s15FT EUDAMED18-10s07FT EUDAMED18-15s30F EUDAMED19-07s15FT EUDAMED
- Description
- The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing. FDA UDI
Identifiers
- Catalog Number
- 17-15s20F FDA UDI
- Primary DI / UDI-DI
- 08809306764263 EUDAMED08809306760630 EUDAMEDFDA UDI08809306760975 EUDAMED08809306764331 EUDAMED08809306760012 EUDAMEDFDA UDI08809306764270 EUDAMED08809306761033 EUDAMED08809306761064 EUDAMED08809306761897 EUDAMED08809306760548 EUDAMED08809306764041 EUDAMED08809306761835 EUDAMED08809306761859 EUDAMED08809306760753 EUDAMED08809306761989 EUDAMED
- Basic UDI-DI
- B-08809306764263 EUDAMEDB-08809306760630 EUDAMEDB-08809306760975 EUDAMEDB-08809306764331 EUDAMEDB-08809306760012 EUDAMEDB-08809306764270 EUDAMEDB-08809306761033 EUDAMEDB-08809306761064 EUDAMEDB-08809306761897 EUDAMEDB-08809306760548 EUDAMEDB-08809306764041 EUDAMEDB-08809306761835 EUDAMEDB-08809306761859 EUDAMEDB-08809306760753 EUDAMEDB-08809306761989 EUDAMED880930676star_EVG EUDAMED
- 510(k) Number
- K172012 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 17 Gauge FDA UDILength — 15 Centimeter FDA UDINeedle Gauge — 19 Gauge FDA UDILength — 10 Centimeter FDA UDI
Category: Open-surgery electrosurgical electrode, monopolar, single-use
star RF electrode-Fixed by Starmed Co., Ltd — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
- Symmetry Olsen — Olsen Medical · Class II
- FlexTrode® Malleable Electrode — ELLIQUENCE LLC · Class II
- 33cm Laparoscopic L-Wire Split; Blue PTFE; Black Insulation; PL — XODUS MEDICAL, INC. · Class II
- 4" Blade Tip Ext Ins; Stainless Steel; Blue Ins; Black Ext Ins — XODUS MEDICAL, INC. · Class II
- CONMED — Conmed Corporation · Class II
- HT-DT-NTW45 — Zhejiang Jinhua Huatong Medical Appliance Co., Ltd · Class IIb
- COLORADO — Stryker Leibinger · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08809306764263 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08809306764263 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- STARmed Co., Ltd.
- EUDAMED SRN
- KR-MF-000008605
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (27)
- EUDAMED 31f77f7f-5adc-48f5-9aa9-f292060e08fe 61 fields · synced Sep 17, 2026
- EUDAMED 7a6a100e-d71e-44d1-a9e2-86ecfd75aa13 61 fields · synced May 16, 2026
- EUDAMED 254a5c48-d089-47fe-af29-ba322b1da8df 61 fields · synced May 17, 2026
- EUDAMED 38bbcc2c-2bf4-40bf-aea4-c9a053a9de38 61 fields · synced May 17, 2026
- EUDAMED 10568932-27e3-4d0a-9809-4a041d254f21 61 fields · synced May 17, 2026
- EUDAMED a191a5dd-5f8f-40f5-89fa-4ec314968fa8 61 fields · synced May 17, 2026
- EUDAMED 0fedbbe3-a96d-4e4f-b7cb-8acd4fd20b3d 61 fields · synced May 17, 2026
- EUDAMED 71a7caaf-ba00-4490-847b-c8d22666c7d4 61 fields · synced May 17, 2026
- EUDAMED 958249f8-c9f5-4a4d-911d-471af2edd449 61 fields · synced May 18, 2026
- EUDAMED 77dedb9f-e7c5-41fc-b69d-d2ce6d7c4433 61 fields · synced May 18, 2026
- EUDAMED c80b3050-ee40-40ca-a026-23b828c748e8 61 fields · synced May 18, 2026
- EUDAMED 1d93a76f-7cfc-4c17-af94-5c2fb6f0d715 61 fields · synced May 18, 2026
- EUDAMED 8a2377ee-c6b0-420f-adbd-422477c445cd 61 fields · synced May 19, 2026
- EUDAMED 28ef7a1e-72bf-46a8-a5e4-ae237e977950 61 fields · synced May 19, 2026
- EUDAMED d1a2c1a4-4b55-45d5-97f5-5bae1dda5b91 61 fields · synced May 19, 2026
- FDA UDI 0e5d1ffb-063c-4a3a-8f13-0c0413023413 38 fields · synced May 30, 2026
- FDA UDI 074ab24a-a135-480b-a6b0-f4018927761e 36 fields · synced May 30, 2026
- EUDAMED e31fdc31-7e04-4c98-bbfa-54f743644061 61 fields · synced Jul 14, 2026
- EUDAMED 9ff39136-6cad-4488-839a-e22b7a475070 61 fields · synced Jul 16, 2026
- EUDAMED 6fc826e4-bdc8-4d2d-a2af-0580753e8ba7 61 fields · synced Jul 17, 2026
- EUDAMED a18c2eec-eea6-40e9-8510-7b32691f948a 61 fields · synced Jul 17, 2026
- EUDAMED daf810ec-cb95-4d85-8509-248f2fc8cc0a 61 fields · synced Jul 24, 2026
- EUDAMED a1ffaabb-8ee6-4cc9-90b6-f4527f55edbe 61 fields · synced Jul 27, 2026
- EUDAMED 90de61e9-0176-4cee-a42e-34d152d79cc6 61 fields · synced Jul 27, 2026
- EUDAMED 167b891f-7a11-4fa6-bde6-87a593de7ea3 61 fields · synced Aug 3, 2026
- EUDAMED 8a852d58-c8fc-4206-96f7-3afbb390cf2a 61 fields · synced Sep 17, 2026
- EUDAMED 13e7efeb-fa58-4229-b018-b2104eeafc31 61 fields · synced Sep 17, 2026