BioProtect Balloon Implant System
K-Number: K222972 · 2023-08-25
ApplicantBioprotect, Ltd.
Decision Date2023-08-25
Product CodeOVB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
BioProtect Balloon Implant System is a medical device manufactured by Bioprotect, Ltd.. It received FDA 510(k) clearance on 2023-08-25 under approval number K222972. The device is classified under product code OVB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BioProtect Balloon Implant System?
BioProtect Balloon Implant System is a medical device that received FDA 510(k) clearance on 2023-08-25. It is manufactured by Bioprotect, Ltd.. The 510(k) number is K222972.
When was BioProtect Balloon Implant System approved by the FDA?
BioProtect Balloon Implant System received FDA 510(k) clearance on 2023-08-25, under approval number K222972.
What company makes BioProtect Balloon Implant System?
BioProtect Balloon Implant System is manufactured by Bioprotect, Ltd..
What is the FDA product code for BioProtect Balloon Implant System?
The FDA product code for BioProtect Balloon Implant System is OVB.
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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.