HFN — Transducer, Pressure, Intrauterine Class II
FDA Device Classification
Classification Details
- Product Code
- HFN
- Device Class
- Class II
- Regulation Number
- 884.2700
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K250897 | clinical innovations | Koala Intrauterine Pressure Catheter (IPC-5000E) | May 22, 2025 |
| K974389 | clinical innovations | KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHE | February 19, 1998 |
| K973746 | clinical innovations | PRE-FILLED SYRINGE FOR KOALA IUP | November 24, 1997 |
| K961424 | utah medical products | INTRAN 500 | July 10, 1996 |
| K954955 | clinical innovations | STORC INTRAUTERINE PRESSURE CATHETER | April 17, 1996 |
| K955443 | utah medical products | INTRAN PLUS | February 20, 1996 |
| K920375 | telos medical | DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER | October 27, 1992 |
| K882224 | telos medical | ULTRANS DISPOSABLE INTRAUTERINE | October 12, 1989 |
| K893503 | laurel medical | SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS | June 12, 1989 |