FDA Product Code
FDA Product Code HFN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.2700
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E) | Clinical Innovations, LLC | 2025-05-22 | Traditional | PDF ↗ |
| K974389 | KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER | Clinical Innovations, Inc. | 1998-02-19 | Traditional | PDF ↗ |
| K973746 | PRE-FILLED SYRINGE FOR KOALA IUP | Clinical Innovations, Inc. | 1997-11-24 | Traditional | PDF ↗ |
| K961424 | INTRAN 500 | Utah Medical Products, Inc. | 1996-07-10 | Traditional | PDF ↗ |
| K954955 | STORC INTRAUTERINE PRESSURE CATHETER | Clinical Innovations, Inc. | 1996-04-17 | Traditional | PDF ↗ |
| K955443 | INTRAN PLUS | Utah Medical Products, Inc. | 1996-02-20 | Traditional | PDF ↗ |
| K920375 | DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER | Telos Medical Corp. | 1992-10-27 | Traditional | PDF ↗ |
| K882224 | ULTRANS DISPOSABLE INTRAUTERINE | Telos Medical Corp. | 1989-10-12 | Traditional | PDF ↗ |
| K893503 | SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS | Laurel Medical Corp. | 1989-06-12 | Traditional | PDF ↗ |
Product code HFN · Class II · Obstetrics/Gynecology. Data: openFDA.