Sterilization Pouch/Roll— 510(k) K251347

Substantially Equivalent

Sterivic Medical Co., Ltd.

FDA 510(k) clearance K251347 for Sterilization Pouch/Roll, Substantially Equivalent on 2026-01-28. Applicant: Sterivic Medical Co., Ltd..

Clearance details

Applicant: Sterivic Medical Co., Ltd.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2025-04-30
Decision date: 2026-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chizhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

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.