K251177
- 510(k) number
- K251177
- Device name
- Self-Seal Sterilization Pouch and Roll
- Applicant
- Guangdong Maidi Medical Co., Ltd. CN
- Product code
- FRG — Wrap, Sterilization
- Decision date
- 2025-12-12
- Date received
- 2025-04-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K251177.pdf
Official FDA record: K251177
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.