Probe Covers (YF-001, YF-002)— 510(k) K240023

Substantially Equivalent

Shenzhen YI Fang Blister Packaging Co., Ltd.

FDA 510(k) clearance K240023 for Probe Covers (YF-001, YF-002), Substantially Equivalent on 2024-03-01. Applicant: Shenzhen YI Fang Blister Packaging Co., Ltd..

Clearance details

Applicant: Shenzhen YI Fang Blister Packaging Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2024-01-03
Decision date: 2024-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.