Koala Intrauterine Pressure Catheter, Koala External Intrauterine Pressure Catheter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K974389 FDA 510(k)
- FDA Product Code
- HFN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.2700 FDA 510(k)
- Regulation Number
- 884.2700 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Koala Intrauterine Pressure Catheter is a Transducer, Pressure, Intrauterine, designed to measure intrauterine pressure during labor. It consists of two variants: an intrauterine catheter for direct pressure monitoring within the uterus and an external catheter for indirect monitoring via a transabdominal or transcervical approach. These devices are intended for use in obstetric settings to assess uterine contractions and fetal well-being during childbirth.
The Koala catheters are supplied as single-use, sterile devices and are classified under FDA 510K and MDR regulatory pathways. They are intended for use in obstetrics/gynecology and are compatible with standard monitoring systems. The intrauterine variant is inserted into the uterine cavity, while the external variant is positioned externally for pressure transduction. Storage and handling follow standard sterile medical device protocols, and their design adheres to Device Class II regulatory standards under 21 CFR 884.2700.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K974389 | Class II | Active |
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Manufacturer
- Manufacturer
- Clinical Innovations, Inc.
Sources (2)
- FDA 510(k) K974389 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026