Balloon Inflation System— 510(k) K232842

Name: FDA 510(k) clearance K232842
Creator: U.S. Food and Drug Administration
Published: 2024-02-29

Substantially Equivalent

Ningbo Hicren Biotechnology Co., Ltd.

FDA 510(k) clearance K232842 for Balloon Inflation System, Substantially Equivalent on 2024-02-29. Applicant: Ningbo Hicren Biotechnology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ningbo Hicren Biotechnology Co., Ltd.
Product code: Code NDN
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2023-09-14
Decision date: 2024-02-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ningbo, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

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.