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FDA 510(k)

Novasight Hybrid System

K-Number: K252945 · 2026-04-17

Decision Date2026-04-17
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Novasight Hybrid System is the device name listed in this FDA 510(k) record. The listed applicant is Conavi Medical, Inc.. It received FDA 510(k) clearance on 2026-04-17 under 510(k) number K252945. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Novasight Hybrid System?

Novasight Hybrid System is a medical device that received FDA 510(k) clearance on 2026-04-17. The listed applicant is Conavi Medical, Inc.. The 510(k) number is K252945.

When did Novasight Hybrid System receive FDA 510(k) clearance?

Novasight Hybrid System received FDA 510(k) clearance on 2026-04-17, under 510(k) number K252945.

Who is the listed applicant for Novasight Hybrid System?

The FDA 510(k) record lists Conavi Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Novasight Hybrid System?

The FDA product code for Novasight Hybrid System is OBJ.

Other records listing Conavi Medical, Inc. 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.

Related Devices (Code: OBJ)

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.

Official Source

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