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FDA 510(k)

Koala Intrauterine Pressure Catheter (IPC-5000E)

K-Number: K250897 · 2025-05-22

ApplicantClinical Innovations, LLC
Decision Date2025-05-22
Product CodeHFN
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Koala Intrauterine Pressure Catheter (IPC-5000E) is a medical device manufactured by Clinical Innovations, LLC. It received FDA 510(k) clearance on 2025-05-22 under approval number K250897. The device is classified under product code HFN. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Koala Intrauterine Pressure Catheter (IPC-5000E)?

Koala Intrauterine Pressure Catheter (IPC-5000E) is a medical device that received FDA 510(k) clearance on 2025-05-22. It is manufactured by Clinical Innovations, LLC. The 510(k) number is K250897.

When was Koala Intrauterine Pressure Catheter (IPC-5000E) approved by the FDA?

Koala Intrauterine Pressure Catheter (IPC-5000E) received FDA 510(k) clearance on 2025-05-22, under approval number K250897.

What company makes Koala Intrauterine Pressure Catheter (IPC-5000E)?

Koala Intrauterine Pressure Catheter (IPC-5000E) is manufactured by Clinical Innovations, LLC.

What is the FDA product code for Koala Intrauterine Pressure Catheter (IPC-5000E)?

The FDA product code for Koala Intrauterine Pressure Catheter (IPC-5000E) is HFN.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT05372679 REDUCED 1 - Renal Denervation Using Ultrasonic Catheter EmitteD Energy Study / ACTIVE_NOT_RECRUITING NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT07179705 Using a Hypotension Prediction Index to Prevent Low Blood Pressure During Dialysis in ICU Patients RECRUITING NCT06297291 Global Paradise System US Post Approval Study RECRUITING NCT05970549 Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage RECRUITING

Other Devices by Clinical Innovations, LLC

K153591ebb Complete Tamponade System K223900babyLance Safety Heelstick (BLM, BLN, BLP) K250298Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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