Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)— 510(k) K220475

Substantially Equivalent

Tianjin Huahong Technology Co., Ltd.

FDA 510(k) clearance K220475 for Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T), Substantially Equivalent on 2022-07-06. Applicant: Tianjin Huahong Technology Co., Ltd..

Clearance details

Applicant: Tianjin Huahong Technology Co., Ltd.
Product code: Code QRL
Advisory panel: General, Plastic Surgery
Date received: 2022-02-18
Decision date: 2022-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tianjin, CN

Download summary PDF View on FDA.gov ↗

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.