Clearance Summary
STATIM 2000 G4 CASSETTE received FDA 510(k) clearance under submission number K112872, sponsored by Scican , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2012-07-10.
- Submission: K112872
- Applicant / Sponsor: Scican , Ltd.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6880
- Decision date: 2012-07-10
Classification & Regulation
This clearance is catalogued under FDA product code FLE and 21 CFR 880.6880, within the General Hospital review panel as a Class II device.