Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Bonvadis®

K-Number: K232655 · 2024-05-22

Decision Date2024-05-22
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Bonvadis® is a medical device manufactured by Stemcyte, Inc.. It received FDA 510(k) clearance on 2024-05-22 under approval number K232655. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bonvadis®?

Bonvadis® is a medical device that received FDA 510(k) clearance on 2024-05-22. It is manufactured by Stemcyte, Inc.. The 510(k) number is K232655.

When was Bonvadis® approved by the FDA?

Bonvadis® received FDA 510(k) clearance on 2024-05-22, under approval number K232655.

What company makes Bonvadis®?

Bonvadis® is manufactured by Stemcyte, Inc..

What is the FDA product code for Bonvadis®?

The FDA product code for Bonvadis® is FRO. This falls under the Anesthesiology category.

Other Devices by Stemcyte, Inc.

Related Devices (Code: FRO)

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.