K252307 is an FDA 510(k) clearance for the Getinge GSS67N Series Steam Sterilizer. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Maquet GmbH (A Getinge Group Company) (Rastatt De-Bw, DE). The FDA issued a Cleared decision on January 22, 2026, 182 days after receiving the submission on July 24, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K252307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2025 |
| Decision Date | January 22, 2026 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FLE - Sterilizer, Steam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6880 |