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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 the device name listed in this FDA 510(k) record. The listed applicant is Clinical Innovations, LLC. It received FDA 510(k) clearance on 2025-05-22 under 510(k) 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. The listed applicant is Clinical Innovations, LLC. The 510(k) number is K250897.

When did Koala Intrauterine Pressure Catheter (IPC-5000E) receive FDA 510(k) clearance?

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

Who is the listed applicant for Koala Intrauterine Pressure Catheter (IPC-5000E)?

The FDA 510(k) record lists Clinical Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Clinical Innovations, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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)K223900babyLance Safety Heelstick (BLM, BLN, BLP)K153591ebb Complete Tamponade System

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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