510(k) K190062 ยท FLE Sterilizer, Steam
STATCLAVE G4 Chamber Autoclave
| Applicant | Scican , Ltd., Toronto, CA |
| Decision | Substantially Equivalent, Jul 26, 2019 |
| Received | Jan 15, 2019 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K190062
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2023 | Scican Ltd. STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.
Model: G4 621103 Open, Classified |
FLE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.