Sterilization Wrap— 510(k) K222151

Substantially Equivalent

Kenpax International Limited

FDA 510(k) clearance K222151 for Sterilization Wrap, Substantially Equivalent on 2023-03-23. Applicant: Kenpax International Limited.

Clearance details

Applicant: Kenpax International Limited
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2022-07-20
Decision date: 2023-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, 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.