FDA 510(k)

BioProtect Balloon Implant™ System

K-Number: K222972 · 2023-08-25

Decision Date2023-08-25

Product CodeOVB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BioProtect Balloon Implant™ System is the device name listed in this FDA 510(k) record. The listed applicant is Bioprotect, Ltd.. It received FDA 510(k) clearance on 2023-08-25 under 510(k) 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. The listed applicant is Bioprotect, Ltd.. The 510(k) number is K222972.

When did BioProtect Balloon Implant™ System receive FDA 510(k) clearance?

BioProtect Balloon Implant™ System received FDA 510(k) clearance on 2023-08-25, under 510(k) number K222972.

Who is the listed applicant for BioProtect Balloon Implant™ System?

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

What is the FDA product code for BioProtect Balloon Implant™ System?

The FDA product code for BioProtect Balloon Implant™ System is OVB.

Related Devices (Code: OVB)

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.

K260119SpaceOAR Vue System (SV-2101)Boston Scientific Corporation K220641Barrigel Injectable GelPalette Life Sciences K202224SpaceOAR SystemBoston Scientific Corporation K182971SpaceOAR Vue HydrogelAugmenix, Inc.K181465SpaceOAR SystemAugmenix, Inc.

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.