510(k) K232992
- Device
- 10THERMA
- Applicant
- Tentech, Inc.
- 510(k) number
- K232992
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-20
- Date received
- 2023-09-22
- Regulation
- 878.4400
- Classification name
- Electrosurgical, Cutting & Coagulation & Accessories
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Dongok Han
- Address
- 3f, Hyungkyung Bldg., 611, Seolleung-Ro, Gangnam-Gu, Seoul KR 06103 06103
FDA Registration Numbers
- 1222780
- 3012259264
- 1221485
- 1423537
- 3030977796
- 3010511300
- 3003898360
- 3010952064
- 1526611
- 3007515069
- 1519132
- 1222313
- 3035374386
- 3031841433
- 1423395
- 3013505983
- 3008816935
- 3013700547
- 2182536
- 3005809810
- 3007113251
- 3016248634
- 2184009
- 3010400367
- 3011986317
- 1047843
- 2936485
- 3005467144
- 2433012
- 1421101
- 3015895045
- 3011559089
- 3005064943
- 2126666
- 9681191
- 1054241
- 3007535734
- 3008868758
- 3001675293
- 3006891627
- 2245304
- 1928237
- 3010836847
- 2183613
- 3007047889
- 1225687
- 3011706110
- 2031966
- 8010273
- 3009756327
- 3013111980
- 3014925413
- 1032347
- 3013596024
- 1219930
- 3008808042
- 3008729892
- 3016087306
- 3013500228
- 9611665
- 3003008746
- 1220477
- 3027713941
- 3007728276
- 2183870
- 3033715699
- 9614969
- 1063285
- 1287329
- 3012510750
- 9614434
- 3008747667
- 3032109
- 3010273872
- 1037007
- 3018242561
- 2085947
- 3012453745
- 3007589150
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809709380565 | 10THERMA / XTHERMA | TENTECH Inc. | 2026-02-27 |
| 08809709380558 | 10THERMA / XTHERMA | TENTECH Inc. | 2026-02-27 |
| 08809709380541 | 10THERMA / XTHERMA | TENTECH Inc. | 2026-02-27 |
| 08809709380534 | 10THERMA / XTHERMA | TENTECH Inc. | 2026-02-27 |
| 08809709380527 | 10THERMA / XTHERMA | TENTECH Inc. | 2026-02-27 |
| 08809709380510 | 10THERMA / XTHERMA | TENTECH Inc. | 2026-02-27 |
| 08809709380503 | 10THERMA / XTHERMA | TENTECH Inc. | 2026-02-27 |
| 08809709380497 | 10THERMA / XTHERMA | TENTECH Inc. | 2026-02-27 |
| 08809709380480 | 10THERMA / XTHERMA | TENTECH Inc. | 2026-02-27 |
| 08809709380473 | 10THERMA / XTHERMA | TENTECH Inc. | 2026-02-27 |
| 08809709380350 | 10THERMA | TENTECH Inc. | 2024-06-28 |
| 08809709380343 | 10THERMA | TENTECH Inc. | 2024-06-28 |
| 08809709380466 | XTHERMA | TENTECH Inc. | 2024-06-25 |
| 08809709380459 | XTHERMA | TENTECH Inc. | 2024-06-25 |
Other 510(k) Records For Product Code GEI
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253134 | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) | Lagis Enterprise Co., Ltd. | 2026-05-20 |
| K260522 | RhinAer+ Stylus | Aerin Medical, Inc. | 2026-05-18 |
| K253917 | ARION ARC System | Plasma Surgical, Inc. | 2026-04-10 |
| K253777 | Ascblue (8010) | Ascblue Corporation | 2026-04-10 |
| K260466 | Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) | Zhejiang shuyou Surgical Instrument Co., Ltd. | 2026-04-07 |
| K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | 2026-04-06 |
| K253405 | Prana System | Prana Surgical | 2026-04-01 |
| K254122 | FLOW FLEXTEND Wand (72290039) | ArthroCare Corporation | 2026-03-30 |
| K260255 | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | Aventix Medical, Inc. | 2026-03-27 |
| K253680 | LYNX COBLATION Laryngeal Wand (72290254) | ArthroCare Corporation | 2026-03-25 |
| K253750 | BTL-785NEH | BTL Industries, Inc. | 2026-03-17 |
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | Gyrus Acmi, Inc. | 2026-03-02 |
| K260287 | SP Electrocautery Device (SP20) | Single Pass, Inc. | 2026-02-24 |
| K251813 | CURIS II RF Generator (REF 360100-05) | Sutter Medizintechnik GmbH | 2026-02-11 |
| K251836 | Dermatrix Duo | Shenzhen Gsd Technology Co., Ltd. | 2026-02-06 |