Sterilization Pouches and Reels— 510(k) K242898

Substantially Equivalent

Shanghai Jianzhong Medical Packaging Co., Ltd.

FDA 510(k) clearance K242898 for Sterilization Pouches and Reels, Substantially Equivalent on 2025-02-21. Applicant: Shanghai Jianzhong Medical Packaging Co., Ltd..

Clearance details

Applicant: Shanghai Jianzhong Medical Packaging Co., Ltd.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2024-09-23
Decision date: 2025-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, 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.