Storc Intrauterine Pressure Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K954955 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 Storc Intrauterine Pressure Catheter is a disposable, sterile, single-patient-use intrauterine pressure monitoring system used during labor and delivery. It features a pressure sensor at the catheter tip and a soft elastomeric tip to reduce perforation risk, with a lumen containing a female luer connector for amniotic fluid access.
The device is operated by clinicians in clinical settings and is intended for single-patient use. It is FDA 510(k) cleared with product code HFN and device class 2. The materials used in the STORC have undergone independent lab testing for biocompatibility and infection safety, with clinical studies including physician evaluation verifying its safe nature.
Frequently asked questions
What is the STORC Intrauterine Pressure Catheter used for?
The STORC Intrauterine Pressure Catheter is a disposable, sterile device used for intrauterine pressure monitoring during labor and delivery. It features a pressure sensor at the catheter tip and a soft elastomeric tip to reduce perforation risk.
Is the STORC Intrauterine Pressure Catheter single-use or reusable?
The STORC Intrauterine Pressure Catheter is designed for single-patient use only. It is a disposable device intended to be used once and then discarded to ensure patient safety and prevent cross-contamination.
What are the key features of the STORC Intrauterine Pressure Catheter?
The STORC features a pressure sensor at the catheter tip for accurate intrauterine pressure monitoring, a soft elastomeric tip to reduce perforation risk, and a lumen containing a female luer connector for amniotic fluid access. It is sterile and designed for single-patient use.
What is the regulatory status of the STORC Intrauterine Pressure Catheter?
The STORC Intrauterine Pressure Catheter is FDA 510(k) cleared with product code HFN and device class 2. It has undergone independent lab testing for biocompatibility and infection safety, with clinical studies including physician evaluation verifying its safe nature.
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. Sources consulted: STORC INTRAUTERINE PRESSURE CATHETER (K954955) — FDA 510 (k) | Innolitics, fda.innolitics.com, LABORIE Medical Technologies to Acquire Clinical Innovations
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K954955 | Class II | Active |
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Manufacturer
- Manufacturer
- Clinical Innovations, Inc.
Sources (1)
- FDA 510(k) K954955 24 fields · synced Sep 25, 2026