Heel Incision Safety Lancet— 510(k) K210745

Substantially Equivalent

SteriLance Medical (Suzhou), Inc.

FDA 510(k) clearance K210745 for Heel Incision Safety Lancet, Substantially Equivalent on 2021-08-26. Applicant: SteriLance Medical (Suzhou), Inc..

Clearance details

Applicant: SteriLance Medical (Suzhou), Inc.
Product code: Code FMK
Advisory panel: General, Plastic Surgery
Date received: 2021-03-12
Decision date: 2021-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.