510(k) K260122— Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)

Substantially Equivalent

SteriLance Medical (Suzhou), Inc.

Clearance details

Applicant: SteriLance Medical (Suzhou), Inc.
Product code: Code QRL
Advisory panel: General, Plastic Surgery
Date received: 2026-01-15
Decision date: 2026-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Adverse events under product code QRL

product code QRL

Other: 1
Total: 1

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.