Getinge GSS67N Series Steam Sterilizer— 510(k) K252307
Substantially EquivalentMaquet GmbH (A Getinge Group Company)
FDA 510(k) clearance K252307 for Getinge GSS67N Series Steam Sterilizer, Substantially Equivalent on 2026-01-22. Applicant: Maquet GmbH (A Getinge Group Company). Device class: 2.
Clearance details
- Applicant
- Maquet GmbH (A Getinge Group Company)
- Product code
- Code FLE
- Device class
- Class 2
- Regulation
- 21 CFR 880.6880
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rastatt De-Bw, DE
Recent devices under product code FLE
view allAdverse events under product code FLE
product code FLE- Malfunction
- 444
- Total
- 444
Source: openFDA MAUDE database, through . 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.