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FDA 510(k)

CoAptix S System

K-Number: K252699 · 2026-04-10

ApplicantUniversity of Utah, Department of Orthopaedics
Decision Date2026-04-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CoAptix S System is the device name listed in this FDA 510(k) record. The listed applicant is University of Utah, Department of Orthopaedics. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K252699. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoAptix S System?

CoAptix S System is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is University of Utah, Department of Orthopaedics. The 510(k) number is K252699.

When did CoAptix S System receive FDA 510(k) clearance?

CoAptix S System received FDA 510(k) clearance on 2026-04-10, under 510(k) number K252699.

Who is the listed applicant for CoAptix S System?

The FDA 510(k) record lists University of Utah, Department of Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoAptix S System?

The FDA product code for CoAptix S System is HWC. This falls under the Cardiovascular category.

Other records listing University of Utah, Department of Orthopaedics 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.

K230867Bone Bolt System

Related Devices (Code: HWC)

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.

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Official Source

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

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