LM-9300 Plus Lithotripter— 510(k) K213772

Substantially Equivalent

Lite-Med, Inc.

FDA 510(k) clearance K213772 for LM-9300 Plus Lithotripter, Substantially Equivalent on 2023-01-19. Applicant: Lite-Med, Inc..

Clearance details

Applicant: Lite-Med, Inc.
Product code: Code LNS
Advisory panel: Gastroenterology, Urology
Date received: 2021-12-02
Decision date: 2023-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code LNS

product code LNS

Death: 4
Injury: 320
Total: 324

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.