HFN
- Product code
- HFN
- Device name
- Transducer, Pressure, Intrauterine
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.2700
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 0 (direct download)
- 510(k) clearances (all years, FDA)
- 9 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250897 | 2025-05-22 | Clinical Innovations, LLC | Koala Intrauterine Pressure Catheter (IPC-5000E) | FDA |
Official FDA classification page: HFN
Classification and pathway per current FDA publications. Data from openFDA (CC0).