K252307
- 510(k) number
- K252307
- Device name
- Getinge GSS67N Series Steam Sterilizer
- Applicant
- Maquet GmbH (A Getinge Group Company) DE
- Product code
- FLE — Sterilizer, Steam
- Decision date
- 2026-01-22
- Date received
- 2025-07-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K252307.pdf
Official FDA record: K252307
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.