BiliWrap
FDA 510(k) clearance K243372 · decided 2025-05-29
Clearance details
- K-number
- K243372
- Device name
- BiliWrap
- Applicant
- Gerium Medical, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-10-30
- Decision date
- 2025-05-29
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- LBI
- Device class
- 2
- Regulation number
- 880.5700
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Yavne, IL
- Third-party review
- No
- Expedited review
- No
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| BiliLux (K172656) | Draeger Medical Systems, Inc. | 2018-05-01 |
| Skylife (K170585) | Neolight, LLC | 2017-10-27 |
| Bilicocoon™ Phototherapy System (K163526) | Neomedlight | 2017-10-06 |
| neoBLUE compact LED Phototherapy System (K160745) | Natus Medical Incorporated | 2016-12-12 |
| Airborne Phototherapy Light (K160238) | International Biomedical | 2016-06-14 |
| neoBLUE® LED Phototherapy System (K160305) | Natus Medical Incorporated | 2016-05-27 |
| BT-400 (K142332) | Bio-Med USA | 2015-03-20 |
Recalls involving this device
No recalls on record reference this clearance.