FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)
K Number: K240447
·
Decision May 5, 2025
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
5
Applicant Total
2
Review Days
445
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Basic Information
- Device Name
- ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)
- K Number
- K240447
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Thermasolutions, LLC
- Date Received
- February 15, 2024
- Decision Date
- May 5, 2025
- Product Code
- MLW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MLW | Warmer, Peritoneal Dialysate | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MLW), ordered by most recent decision date.
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Other Clearances by Thermasolutions, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K222575 | HurriChem Device Kit | Dec 6, 2022 | Substantially Equivalent |