Clearance Summary
ASAP MUITISCOPE received FDA 510(k) clearance under submission number K121261, sponsored by Asap Endoscopic Products GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2013-01-08.
- Submission: K121261
- Applicant / Sponsor: Asap Endoscopic Products GmbH
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2013-01-08
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.