Kyphoplasty Balloon Dilatation Catheters— 510(k) K252458

Name: FDA 510(k) clearance K252458
Creator: U.S. Food and Drug Administration
Published: 2025-11-03

Substantially Equivalent

Shanghai Lange Medtech Co., Ltd.

FDA 510(k) clearance K252458 for Kyphoplasty Balloon Dilatation Catheters, Substantially Equivalent on 2025-11-03. Applicant: Shanghai Lange Medtech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Lange Medtech Co., Ltd.
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 2025-08-05
Decision date: 2025-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.