Perpak Sterilization Tyvek Pouch— 510(k) K241123

Substantially Equivalent

Km Corp.

FDA 510(k) clearance K241123 for Perpak Sterilization Tyvek Pouch, Substantially Equivalent on 2024-09-18. Applicant: Km Corp..

Clearance details

Applicant: Km Corp.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2024-04-23
Decision date: 2024-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gangwon-Do, KR

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.