TRANBERG Thermoguide Therapy System
FDA 510(k) clearance K214125 · decided 2022-09-22
Clearance details
- K-number
- K214125
- Device name
- TRANBERG Thermoguide Therapy System
- Applicant
- Clinical Laserthermia Systems, AB
- Decision
- Substantially Equivalent
- Date received
- 2021-12-30
- Decision date
- 2022-09-22
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- ONO
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Lund, SE
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| NeuroBlate System (K260976) | Monteris Medical | 2026-04-23 |
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| Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) (K251298) | Clinical Laserthermia Systems, AB | 2025-09-04 |
| Visualase V2 MRI-guided Laser Ablation System (9736422) (K250307) | Medtronic Navigation | 2025-05-29 |
| Monteris Medical NeuroBlate System (K240877) | Monteris Medical, | 2024-06-04 |
| Visualase MRI-Guided Laser Ablation System (SW 3.4) (K211269) | Medtronic Navigation, Inc. | 2022-01-07 |
Recalls involving this device
No recalls on record reference this clearance.