510(k) K252458 ยท HRX Arthroscope
Kyphoplasty Balloon Dilatation Catheters
| Applicant | Shanghai Lange Medtech Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Nov 3, 2025 |
| Received | Aug 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252458
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.