BioProtect Balloon Implant System— 510(k) K222972

Name: FDA 510(k) clearance K222972
Creator: U.S. Food and Drug Administration
Published: 2023-08-25

Substantially Equivalent

Bioprotect, Ltd.

FDA 510(k) clearance K222972 for BioProtect Balloon Implant System, Substantially Equivalent on 2023-08-25. Applicant: Bioprotect, Ltd.. Device class: 2.

Clearance details

Applicant: Bioprotect, Ltd.
Product code: Code OVB
Device class: Class 2
Regulation: 21 CFR 892.5725
Advisory panel: Radiology
Date received: 2022-09-27
Decision date: 2023-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tzur Yigal, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVB

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K262151 — SpaceOAR Flex System2026-09-11
K260119 — SpaceOAR Vue System (SV-2101)2026-02-10
K220641 — Barrigel Injectable Gel2022-05-26
K202224 — SpaceOAR System2020-08-28
K182971 — SpaceOAR Vue Hydrogel2019-07-19

Adverse events under product code OVB

product code OVB

Death: 7
Injury: 658
Malfunction: 1,206
Total: 1,871

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.