Intran 500
FDA 510(k) K961424 · Utah Medical Products, Inc.
510(k) numberK961424
Submission
- Device name
- Intran 500
- Applicant
- Utah Medical Products, Inc.
Midvale, UT, US - Received
- April 12, 1996
- Decision date
- July 10, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HFN – Transducer, Pressure, Intrauterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2700
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HFN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E)HFN · Traditional | Clinical Innovations, LLC | 05/22/2025SE |
| K974389 | Koala Intrauterine Pressure Catheter, Koala External Intrauterine Pressure CatheterHFN · Traditional | Clinical Innovations, Inc. | 02/19/1998SE |
| K973746 | Pre-Filled Syringe for Koala IupHFN · Traditional | Clinical Innovations, Inc. | 11/24/1997SE |
| K954955 | Storc Intrauterine Pressure CatheterHFN · Traditional | Clinical Innovations, Inc. | 04/17/1996SE |
| K955443 | Intran PlusHFN · Traditional | Utah Medical Products, Inc. | 02/20/1996SE |
| K920375 | Disposable Intrauterine Pressure TransducerHFN · Traditional | Telos Medical Corp. | 10/27/1992SE |
| K882224 | Ultrans Disposable IntrauterineHFN · Traditional | Telos Medical Corp. | 10/12/1989SE |
| K893503 | Sofsens(Tm) Model LMP-100 Intrauterine Pres. TransHFN · Traditional | Laurel Medical Corp. | 06/12/1989SE |
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Questions and answers
When was Intran 500 cleared by the FDA?
Intran 500 (K961424) received a 510(k) decision of Substantially Equivalent on July 10, 1996, 89 days after the submission was received.
What is the product code of K961424?
The FDA product code is HFN – Transducer, Pressure, Intrauterine, a Class II (moderate risk) device regulated under 21 CFR 884.2700.