K251347
- 510(k) number
- K251347
- Device name
- Sterilization Pouch/Roll
- Applicant
- Sterivic Medical Co., Ltd. CN
- Product code
- FRG — Wrap, Sterilization
- Decision date
- 2026-01-28
- Date received
- 2025-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K251347.pdf
Official FDA record: K251347
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.